Effects of Initial Graft Tension on Anterior Cruciate Ligament Reconstruction
Acronym
Not provided
Organization
Rhode Island HospitalOTHER
Status Module
Record Verification Date
Mar 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2004Actual
Primary Completion Date
Feb 29, 2024Actual
Completion Date
Feb 29, 2024Actual
First Submitted Date
Feb 9, 2007
First Submission Date that Met QC Criteria
Feb 9, 2007
First Posted Date
Feb 13, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 14, 2024
Results First Submitted that Met QC Criteria
Dec 13, 2024
Results First Posted Date
Dec 18, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 12, 2025
Last Update Posted Date
Apr 1, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Braden Fleming, Professor, Rhode Island HospitalPrincipal Investigator
Lead Sponsor
Rhode Island HospitalOTHER
Collaborators
Name
Class
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The anterior cruciate ligament (ACL) is one of four strong ligaments connecting the bones of the knee joint. If overstretched, the ACL can tear. Reconstruction of a torn ACL is now a common surgical procedure. The amount of tension applied to the ACL during reconstruction may indirectly affect the possible onset of arthritis over time. The purpose of this study is to determine the effect of initial graft tension set during ACL reconstruction surgery on the progression of knee arthritis over at least a 15-year period.
Detailed Description
Damage to the ACL is a common injury that usually requires surgical reconstruction to restore function and prevent progression of post-traumatic osteoarthritis. However, the reconstruction procedure frequently causes degenerative changes to the knee joint over time. The amount of tension applied to the ACL during reconstruction may indirectly affect the possible onset of arthritis over time. High tension would result in less joint motion during the initial healing stages, which may make the onset of arthritis less likely. On the other hand, high tension would result in increased compressive forces between the joint surfaces, which could lead to arthritis. The purpose of this study is to evaluate the effect of initial graft tension set during ACL reconstruction surgery on joint cartilage and the development of knee arthritis over at least a 15-year period.
Participants will include candidates for ACL reconstruction surgery using patellar tendon or hamstring tendon grafts. Participants will be randomly assigned to one of two treatment groups:
Low tension (Group 1) participants will receive low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
High-tension (Group 2) participants will receive high-tension treatment with initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Participants will enroll in this 15-year study 1 to 6 weeks prior to ACL surgery. There will be two preoperative study visits: one will include magnetic resonance imaging (MRI) and the other will include a knee evaluation, dynamic function testing, and questionnaires. Postoperative visits occurred immediately following surgery and at 6, 12, 36, 60, 84, 120, 144 and 180 months following surgery. Strength testing, functional testing, x-rays, questionnaires, and a knee exam will occur at most postoperative visits. MRIs will occur at some postoperative visits. An additional group of participants with no evidence of knee injury will serve as a control. The control group will attend all study visits except for the 12-month visit. All participants may be followed for up to 15 years.
Conditions Module
Conditions
Anterior Cruciate Ligament Rupture
Keywords
Knee
Ligament
ACL
Reconstruction
Cartilage
Osteoarthritis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
168Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Low-tension
Experimental
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Procedure: Initial graft tension during ACL reconstruction surgery
High-tension
Experimental
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Procedure: Initial graft tension during ACL reconstruction surgery
Uninjured Control Group
No Intervention
Uninjured age, sex, and race matched control group
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Initial graft tension during ACL reconstruction surgery
Procedure
The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Radiographic Joint Space Narrowing (Midpoint Method)
Medial joint space width measurements were obtained from radiographs preoperatively and postoperatively using the semiflexed metatarsophalangeal view. Radiographs were taken of each knee, and the medial compartment joint space width was measured by calculating the distance between the femoral and tibial intersections with the bisecting midpoint line. Analysis was conducted using a MATLAB program. (Mehta N, Duryea J, Badger GJ, et al. Comparison of 2 Radiographic Techniques for Measurement of Tibiofemoral Joint Space Width. Orthop J Sports Med. 2017;5(9):2325967117728675. Published 2017 Sep 26. doi:10.1177/2325967117728675) Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30 mm over the study period.
This was the first method used for the study. It was used for baseline and 3-year follow-up prior to switching to the 'surface-fit' method at the 7-year follow-up.
3 years
Radiographic Joint Space Narrowing (Surface-Fit Method)
Medial joint space width measurements were obtained from radiographs preoperatively and postoperatively using the semiflexed metatarsophalangeal view. Radiographs were taken of each knee, and the medial compartment joint space width was measured at the midline of the compartment in the coronal plane using a validated computer algorithm.
(Duryea et al., Trainable rule-based algorithm for the measurement of joint space width in digital radiographic images of the knee, Medical Physics 27, 580 (2000); doi: 10.1118/1.598897). Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30mm over the study period.
The surface-fit method was used for the 7-year follow-up and baseline radiographs instead of the Midpoint Method, after confirming less variability across knees within a participant. (Mehta et al. 2017)
7 years
Radiographic Joint Space Narrowing (Kiapour Method)
Joint space width measurements in the medial compartment were calculated from weightbearing radiographs using the semi-flexed metatarsophalangeal view. Radiographs were manually segmented to outline articular surfaces of femur and tibia using Mimics. A custom program in MATLAB developed by Dr. Ata Kiapour was used to calculate joint space width as the perpendicular distance between the femoral condyle and tibial plateau boundaries at 25% of total bicondylar width. Measured JSW values were then scaled using image distances between beads of a calibration standard taped to the fibular head.
This method was used for the baseline, 10-12, and 15-year follow-up as a comparable in-house method to the surface-fit method.
Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30 mm over the study period.
Secondary Outcomes
Measure
Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
15 years
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria for Groups 1 and 2:
ACL injury of only one knee (minor meniscal tears involving less than 1/3 of the meniscus are allowed)
Candidate for ACL reconstruction surgery using a bone-patellar tendon-bone graft or a four-stranded hamstring tendon graft (looped semitendinosus and gracilis muscles)
Tegner activity score of 5 or greater, indicating participant is at least moderately active
Exclusion Criteria for Groups 1 and 2:
ACL tear that has occurred more than 12 months prior to surgery
Moderate-sized fissures or lesions in knee articular cartilage
Meniscal tears requiring partial removal of meniscus (tears larger than 1/3 of the meniscus)
Inclusion Criteria for the Control Group:
Tegner activity score of 5 or greater, indicating participant is at least moderately active
Exclusion Criteria for All Participants:
Previous injury to either knee
Increased laxity of the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL), as compared to the uninjured knee
Radiographic evidence of degenerative arthritis
Pregnancy
Any disease that might place a participant at high risk for articular cartilage damage (e.g., rheumatoid arthritis, osteoporosis, metabolic diseases)
Brady MF, Bradley MP, Fleming BC, Fadale PD, Hulstyn MJ, Banerjee R. Effects of initial graft tension on the tibiofemoral compressive forces and joint position after anterior cruciate ligament reconstruction. Am J Sports Med. 2007 Mar;35(3):395-403. doi: 10.1177/0363546506294363. Epub 2007 Jan 11.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Data are available upon request. Once the study is completed and published, the data records will be made available through ClinicalTrials.gov
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame
Data are available upon request at any time. There is no end date. Data will also be posted on ClinicalTrials.gov with no end date.
Access Criteria
Available upon request to the PI. Data on ClinicalTrials.gov are publicly available.
URL
Not provided
Patients between the age of 15-50 with isolated unilateral ACL injuries were considered for eligibility. Patients were excluded from the study if they required meniscectomy greater than 1/3 of meniscus, showed increased laxity of knee ligaments, or had a history of previous knee injuries and/or developing osteoarthritis.
Of 108 subjects initially recruited to tension groups, 18 were excluded pre- or during surgery.
Recruitment Details
Recruitment took place between February 2004 and February 2007 in clinics of participating doctors: Dr. Paul D. Fadale, Dr. Michael J. Hulstyn, and Dr. Robert M. Shalvoy.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
FG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
FG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00046 subjects
FG00144 subjects
FG00260 subjects
6 Months
FG00039 subjects
FG00137 subjects
FG0020 subjects
1 Year
FG00035 subjects
FG00134 subjects
FG00248 subjects
3 Years
FG00044 subjects
FG00141 subjects
FG00248 subjects
7 Years
FG00036 subjects
FG00136 subjects
FG00234 subjects
10-12 Years
FG00032 subjects
FG00128 subjects
FG00235 subjects
COMPLETED
FG00026 subjects
FG00121 subjects
FG00230 subjects
NOT COMPLETED
FG00020 subjects
FG00123 subjects
FG00230 subjects
Type
Comment
Reasons
Lost to Follow-up
FG00020 subjects
FG00123 subjects
FG00230 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Radiographic Joint Space Narrowing (Midpoint Method)
Medial joint space width measurements were obtained from radiographs preoperatively and postoperatively using the semiflexed metatarsophalangeal view. Radiographs were taken of each knee, and the medial compartment joint space width was measured by calculating the distance between the femoral and tibial intersections with the bisecting midpoint line. Analysis was conducted using a MATLAB program. (Mehta N, Duryea J, Badger GJ, et al. Comparison of 2 Radiographic Techniques for Measurement of Tibiofemoral Joint Space Width. Orthop J Sports Med. 2017;5(9):2325967117728675. Published 2017 Sep 26. doi:10.1177/2325967117728675) Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30 mm over the study period.
This was the first method used for the study. It was used for baseline and 3-year follow-up prior to switching to the 'surface-fit' method at the 7-year follow-up.
Insufficient time for imaging; loss to follow-up.
Posted
Mean
95% Confidence Interval
mm
3 years
ID
Title
Description
Adverse Events Module
Frequency Threshold
0
Time Frame
Adverse events were self-reported by subjects at each follow-up time-point beginning at 6 months and ending with the 15-year follow-up.
Description
Subjects reported injuries using a 'subsequent injuries survey.' There were no study related adverse events, as all events reported are expected surgical events.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
contralateral ACL tear
Musculoskeletal and connective tissue disorders
Systematic Assessment
More Info Module
Limitations and Caveats
The study participant retention rate dropped over time.
It should be noted that the method used to determine the Radiographic Joint Space Narrowing outcome measure changed overtime. To account for this, the baseline measure was determined with each method at each timepoint.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
15 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
15 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
15 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
15 years
Knee Joint Laxity
Difference in Anterior-Posterior (A-P) knee laxity value; A-P laxity is defined as the amount of A-P directed translation of the tibia (relative to the femur) between the shear load limits of -90 N (posterior) and 133 N (anterior).
15 years
Limb Strength International Knee Documentation Committee (IKDC) Score
Clinical outcome was assessed using the 2000 IKDC Knee Examination Score (http://www.sportsmed.org). The IKDC scores evaluate 4 categories: function, symptoms, range of knee motion, and clinical examination.The IKDC score rates knees as normal (A), nearly normal (B), abnormal (C), and severely abnormal (D), with the final IKDC rating based on the score of the worst category.
15 years
Short Form-36 (SF-36) Health Survey Physical Functioning
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
15 years
Short Form-36 (SF-36) Health Survey Physical Role
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
15 years
Short Form-36 (SF-36) Health Survey General Health
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
15 years
Short Form-36 (SF-36) Health Survey Bodily Pain
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
15 years
Short Form-36 (SF-36) Health Survey Vitality
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
15 years
Short Form-36 (SF-36) Health Survey Social Function
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
15 years
Short Form-36 (SF-36) Health Survey Emotional Role
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
15 years
Short Form-36 (SF-36) Health Survey Mental Health
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
15 years
Muscle Atrophy
Thigh circumference 6 cm above the joint line for injured and contralateral knees. Muscle atrophy difference calculated as index-contralateral circumference.
15 years
Whole Organ Magnetic Resonance Image Score (WORMS)
The OA status of the knee was assessed using the semiquantitative Whole Organ Magnetic Resonance Imaging Score (WORMS).The score uses magnetic resonance imaging (MRI) sequences to grade 14 independent features: cartilage signal and morphological characteristics, subarticular bone marrow abnormality, subarticular cysts, subarticular bone attrition, and marginal osteophytes evaluated in 15 regions. The condition of the menisci, cruciate and collateral ligaments, synovitis, loose bodies, and periarticular cysts was also included for a total possible score of 332 points.
0-indicates no damage in anatomical landmarks assessed. 332-severe damage to the anatomical landmarks assessed.
15 years
One-legged Hop Test
Ratio of hop distance on the injured knee to the hop distance on the contralateral uninjured knee.
15 years
Modified OsteoArthritis Research Society International (OARSI) Score
OARSI-The overall condition of the knee joints of both surgical and contralateral limbs were graded on radiographs by a radiologist. (0-83). 83-severe damage.0- no damage. The difference of the score between surgical and contralateral limbs is also presented.
15 years
Isokinetic Strength
Strength of quadriceps muscles was quantified by averaging the peak torques of 3 repetitions and normalizing these values with respect to body weight.Percent torque of surgical compared to contralateral is presented. If the quadriceps muscle of the surgical limb had the same peak torque as the contralateral, it would be 100%.
7 years
Tegner Activity Scale
The Tegner activity scale graded activity level based on work and sports activity on a scale of 1-10 with 1 representing physical disability due to knee problems and 10 indicating national or international level soccer participation.
Bowers ME, Tung GA, Trinh N, Leventhal E, Crisco JJ, Kimia B, Fleming BC. Effects of ACL interference screws on articular cartilage volume and thickness measurements with 1.5 T and 3 T MRI. Osteoarthritis Cartilage. 2008 May;16(5):572-8. doi: 10.1016/j.joca.2007.09.010. Epub 2007 Oct 22.
Miranda DL, Rainbow MJ, Crisco JJ, Fleming BC. Kinematic differences between optical motion capture and biplanar videoradiography during a jump-cut maneuver. J Biomech. 2013 Feb 1;46(3):567-73. doi: 10.1016/j.jbiomech.2012.09.023. Epub 2012 Oct 22.
Miranda DL, Schwartz JB, Loomis AC, Brainerd EL, Fleming BC, Crisco JJ. Static and dynamic error of a biplanar videoradiography system using marker-based and markerless tracking techniques. J Biomech Eng. 2011 Dec;133(12):121002. doi: 10.1115/1.4005471.
Coats-Thomas MS, Miranda DL, Badger GJ, Fleming BC. Effects of ACL reconstruction surgery on muscle activity of the lower limb during a jump-cut maneuver in males and females. J Orthop Res. 2013 Dec;31(12):1890-6. doi: 10.1002/jor.22470. Epub 2013 Aug 21.
Rainbow MJ, Miranda DL, Cheung RT, Schwartz JB, Crisco JJ, Davis IS, Fleming BC. Automatic determination of an anatomical coordinate system for a three-dimensional model of the human patella. J Biomech. 2013 Aug 9;46(12):2093-6. doi: 10.1016/j.jbiomech.2013.05.024. Epub 2013 Jun 20.
Miranda DL, Fadale PD, Hulstyn MJ, Shalvoy RM, Machan JT, Fleming BC. Knee biomechanics during a jump-cut maneuver: effects of sex and ACL surgery. Med Sci Sports Exerc. 2013 May;45(5):942-51. doi: 10.1249/MSS.0b013e31827bf0e4.
Ware JK, Owens BD, Akelman MR, Karamchedu NP, Fadale PD, Hulstyn MJ, Shalvoy RM, Badger GJ, Fleming BC. Preoperative KOOS and SF-36 Scores Are Associated With the Development of Symptomatic Knee Osteoarthritis at 7 Years After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2018 Mar;46(4):869-875. doi: 10.1177/0363546517751661. Epub 2018 Feb 5.
Kiapour AM, Yang DS, Badger GJ, Karamchedu NP, Murray MM, Fadale PD, Hulstyn MJ, Shalvoy RM, Fleming BC. Anatomic Features of the Tibial Plateau Predict Outcomes of ACL Reconstruction Within 7 Years After Surgery. Am J Sports Med. 2019 Feb;47(2):303-311. doi: 10.1177/0363546518823556. Epub 2019 Jan 14.
Costa MQ, Badger GJ, Chrostek CA, Carvalho OD, Faiola SL, Fadale PD, Hulstyn MJ, Gil HC, Shalvoy RM, Fleming BC. Effects of Initial Graft Tension and Patient Sex on Knee Osteoarthritis Outcomes After ACL Reconstruction: A Randomized Controlled Clinical Trial With 10- to 12-Year Follow-up. Am J Sports Med. 2022 Nov;50(13):3510-3521. doi: 10.1177/03635465221124917. Epub 2022 Oct 19.
Breker AN, Badger GJ, Kiapour AM, Costa MQ, Fleming EN, Ferrara SL, Chrostek CA, Fadale PD, Hulstyn MJ, Shalvoy RM, Gil HC, Fleming BC. Effect of Initial Graft Tension on Knee Osteoarthritis Outcomes After ACL Reconstruction: A Randomized Controlled Clinical Trial With 15-Year Follow-up. Orthop J Sports Med. 2025 Mar 4;13(3):23259671251320972. doi: 10.1177/23259671251320972. eCollection 2025 Mar.
BG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
BG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
BG003
Total
Total of all reporting groups
46
BG00144
BG00260
BG003150
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00046
ParticipantsBG00144
ParticipantsBG00260
ParticipantsBG003150
Title
Measurements
BG00023.9± 9.26
BG00123.1± 7.19
BG00225.3± 6.15
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00046
ParticipantsBG00144
ParticipantsBG00260
ParticipantsBG003150
Title
Measurements
Female
BG00022
BG00126
BG00226
BG003
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
ParticipantsBG00046
ParticipantsBG00144
ParticipantsBG00260
ParticipantsBG003150
Title
Measurements
BG00043
BG00136
BG00252
BG003
Black
ParticipantsBG00046
ParticipantsBG00144
ParticipantsBG00260
ParticipantsBG003150
Asian
ParticipantsBG00046
ParticipantsBG00144
ParticipantsBG00260
ParticipantsBG003150
Native Hawaiian or Other Pacific Islander
ParticipantsBG00046
ParticipantsBG00144
ParticipantsBG00260
ParticipantsBG003150
More than one race
ParticipantsBG00046
ParticipantsBG00144
ParticipantsBG00260
ParticipantsBG003150
Hispanic or Latino
ParticipantsBG00046
ParticipantsBG00144
ParticipantsBG00260
ParticipantsBG003150
Unknown/Not Reported
ParticipantsBG00046
ParticipantsBG00144
ParticipantsBG00260
ParticipantsBG003150
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
ParticipantsBG00046
ParticipantsBG00144
ParticipantsBG00260
ParticipantsBG003150
Title
Measurements
BG00046
BG00144
BG00260
BG003
BMI
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
ParticipantsBG00046
ParticipantsBG00144
ParticipantsBG00260
ParticipantsBG003150
Title
Measurements
BG00024.7± 3.20
BG00124.5± 3.56
BG00223.9± 3.14
BG003
Time from injury to surgery
Control subjects did not undergo ACL reconstruction and were not included in the calculations.
5 patients in the high-tension group and 1 patient in the low-tension group did not report an exact injury date and are excluded from this variable.
Mean
Standard Deviation
days
Title
Denominators
Categories
ParticipantsBG00045
ParticipantsBG00139
ParticipantsBG0020
ParticipantsBG00384
Title
Measurements
BG000112± 86.5
BG001116± 119
BG003114± 102
Graft type
Control patients did not undergo ACL reconstruction and therefore were not assigned a graft type.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00046
ParticipantsBG00144
ParticipantsBG0020
ParticipantsBG00390
Title
Measurements
Autologous Patellar Tendon
BG00031
BG00127
BG00358
Autologous Hamstring Tendon
BG000
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00258
Title
Measurements
OG0000.0613(-0.1640 to 0.2870)
OG0010.0634(-0.1260 to 0.2530)
OG002-0.0321(-0.1850 to 0.1210)
1-year
ParticipantsOG00038
ParticipantsOG00137
ParticipantsOG00246
Title
Measurements
OG000
3-years
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00236
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 3-year analysis.
ANOVA
.27
Superiority
Primary
Radiographic Joint Space Narrowing (Surface-Fit Method)
Medial joint space width measurements were obtained from radiographs preoperatively and postoperatively using the semiflexed metatarsophalangeal view. Radiographs were taken of each knee, and the medial compartment joint space width was measured at the midline of the compartment in the coronal plane using a validated computer algorithm.
(Duryea et al., Trainable rule-based algorithm for the measurement of joint space width in digital radiographic images of the knee, Medical Physics 27, 580 (2000); doi: 10.1118/1.598897). Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30mm over the study period.
The surface-fit method was used for the 7-year follow-up and baseline radiographs instead of the Midpoint Method, after confirming less variability across knees within a participant. (Mehta et al. 2017)
Insufficient time for imaging; loss to follow-up. Baseline images of subjects presented at 7-year follow-up were analyzed again retroactively with this method.
Posted
Mean
95% Confidence Interval
mm
7 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00023
ParticipantsOG00121
ParticipantsOG00224
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 7-year analysis.
ANOVA
.08
Superiority
Primary
Radiographic Joint Space Narrowing (Kiapour Method)
Joint space width measurements in the medial compartment were calculated from weightbearing radiographs using the semi-flexed metatarsophalangeal view. Radiographs were manually segmented to outline articular surfaces of femur and tibia using Mimics. A custom program in MATLAB developed by Dr. Ata Kiapour was used to calculate joint space width as the perpendicular distance between the femoral condyle and tibial plateau boundaries at 25% of total bicondylar width. Measured JSW values were then scaled using image distances between beads of a calibration standard taped to the fibular head.
This method was used for the baseline, 10-12, and 15-year follow-up as a comparable in-house method to the surface-fit method.
Subjects are identified as having radiographic signs of OA if they exhibit a change in the medial or lateral compartments greater than 0.30 mm over the study period.
Insufficient time for imaging; loss to follow-up. Method was used retroactively for existing baseline images.
Posted
Mean
95% Confidence Interval
mm
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.22
Superiority
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
Some subjects omitted responses from questions pertaining to the symptoms score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.0078
Superiority
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
Some subjects omitted responses from questions pertaining to the pain score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.0018
Superiority
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
Some subjects omitted responses from questions pertaining to the ADL score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.015
Superiority
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
Some subjects omitted responses from questions pertaining to the sport score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00041
ParticipantsOG00141
ParticipantsOG00259
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.003
Superiority
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life
The five dimensions of Knee Osteoarthritis Outcome Score were scored separately: pain , symptoms ,activities of daily life function, sport and recreation function, and knee-related quality of life . Each sub score has a 0-100 scale. 0- extreme knee problems and 100- no knee problems.
Some subjects omitted responses from questions pertaining to the QOL score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00259
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.0006
Superiority
Secondary
Knee Joint Laxity
Difference in Anterior-Posterior (A-P) knee laxity value; A-P laxity is defined as the amount of A-P directed translation of the tibia (relative to the femur) between the shear load limits of -90 N (posterior) and 133 N (anterior).
Loss to follow-up or questionnaire-only participant
Posted
Mean
95% Confidence Interval
Millimeters
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00046
ParticipantsOG00144
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.15
Superiority
Secondary
Limb Strength International Knee Documentation Committee (IKDC) Score
Clinical outcome was assessed using the 2000 IKDC Knee Examination Score (http://www.sportsmed.org). The IKDC scores evaluate 4 categories: function, symptoms, range of knee motion, and clinical examination.The IKDC score rates knees as normal (A), nearly normal (B), abnormal (C), and severely abnormal (D), with the final IKDC rating based on the score of the worst category.
Loss to follow-up or questionnaire-only subject
Posted
Count of Participants
Participants
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00260
Title
Measurements
A
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
Chi-squared
.34
Superiority
Secondary
Short Form-36 (SF-36) Health Survey Physical Functioning
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Some subjects omitted responses from questions pertaining to the physical functioning score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.17
Superiority
Secondary
Short Form-36 (SF-36) Health Survey Physical Role
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Some subjects omitted responses from questions pertaining to the physical role score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.25
Superiority
Secondary
Short Form-36 (SF-36) Health Survey General Health
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Some subjects omitted responses from questions pertaining to the general health score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.61
Superiority
Secondary
Short Form-36 (SF-36) Health Survey Bodily Pain
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Some subjects omitted responses from questions pertaining to the bodily pain score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.15
Superiority
Secondary
Short Form-36 (SF-36) Health Survey Vitality
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Some subjects omitted responses from questions pertaining to the vitality score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.53
Superiority
Secondary
Short Form-36 (SF-36) Health Survey Social Function
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Some subjects omitted responses from questions pertaining to the social function score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.82
Superiority
Secondary
Short Form-36 (SF-36) Health Survey Emotional Role
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Some subjects omitted responses from questions pertaining to the emotional role score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.03
Superiority
Secondary
Short Form-36 (SF-36) Health Survey Mental Health
The SF-36 evaluates general health related to physical function, role limitations, bodily pain, vitality, social functioning, mental health, and health transition. Each sub score is on a 0-100 scale. 100 indicates no problems and 0 indicates severe problems.
Some subjects omitted responses from questions pertaining to the mental health score. These subjects were omitted from the overall N for score calculations.
Loss to follow-up between time-points accounts for the remaining population differences. Control subjects were not assessed at 6 months.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.67
Superiority
Secondary
Muscle Atrophy
Thigh circumference 6 cm above the joint line for injured and contralateral knees. Muscle atrophy difference calculated as index-contralateral circumference.
Participant population declined due to loss to follow-up or insufficient time to test at the appointment. Control subjects were not tested at the 6-month follow-up.
Posted
Mean
95% Confidence Interval
centimeters
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00258
Title
Measurements
Secondary
Whole Organ Magnetic Resonance Image Score (WORMS)
The OA status of the knee was assessed using the semiquantitative Whole Organ Magnetic Resonance Imaging Score (WORMS).The score uses magnetic resonance imaging (MRI) sequences to grade 14 independent features: cartilage signal and morphological characteristics, subarticular bone marrow abnormality, subarticular cysts, subarticular bone attrition, and marginal osteophytes evaluated in 15 regions. The condition of the menisci, cruciate and collateral ligaments, synovitis, loose bodies, and periarticular cysts was also included for a total possible score of 332 points.
0-indicates no damage in anatomical landmarks assessed. 332-severe damage to the anatomical landmarks assessed.
Insufficient time for imaging; loss to follow-up.
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00017
ParticipantsOG00116
ParticipantsOG00224
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.051
Superiority
Secondary
One-legged Hop Test
Ratio of hop distance on the injured knee to the hop distance on the contralateral uninjured knee.
Some surgical subjects declined to perform due to knee instability. Other subjects had insufficient time to test. There was loss to follow-up at later timepoints.
Posted
Mean
95% Confidence Interval
percentage of contralateral knee
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00045
ParticipantsOG00141
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results were from the 15-year analysis.
ANOVA
.14
Superiority
Secondary
Modified OsteoArthritis Research Society International (OARSI) Score
OARSI-The overall condition of the knee joints of both surgical and contralateral limbs were graded on radiographs by a radiologist. (0-83). 83-severe damage.0- no damage. The difference of the score between surgical and contralateral limbs is also presented.
Insufficient time for imaging; loss to follow-up
Posted
Mean
95% Confidence Interval
score on a scale
15 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00126
ParticipantsOG00231
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.067
Superiority
Secondary
Isokinetic Strength
Strength of quadriceps muscles was quantified by averaging the peak torques of 3 repetitions and normalizing these values with respect to body weight.Percent torque of surgical compared to contralateral is presented. If the quadriceps muscle of the surgical limb had the same peak torque as the contralateral, it would be 100%.
At baseline, machine measuring isokinetic strength was unavailable for many surgical subjects. Population discrepancies at later time-points include loss to follow-up and machine unavailability. Isokinetic strength was no longer measured after the 7-year follow-up.
Posted
Mean
95% Confidence Interval
percentage of index/contralateral limbs
7 years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results were from the 7-year analysis.
ANOVA
.54
Superiority
Secondary
Tegner Activity Scale
The Tegner activity scale graded activity level based on work and sports activity on a scale of 1-10 with 1 representing physical disability due to knee problems and 10 indicating national or international level soccer participation.
Subjects were lost to follow-up throughout the study.
Posted
Mean
95% Confidence Interval
score on a scale
15-years
ID
Title
Description
OG000
Low-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
OG002
Uninjured Control Group
Uninjured age, sex, and race matched control group
Units
Counts
Participants
OG00046
OG00144
OG00260
Title
Denominators
Categories
Baseline
ParticipantsOG00046
ParticipantsOG00144
ParticipantsOG00260
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
These results are from the 15-year analysis.
ANOVA
.08
Superiority
0
46
0
46
11
46
EG001
High-tension
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Initial graft tension during ACL reconstruction surgery: The amount of tension that is applied to the graft at the time of fixation is being performed with the knee in two different positions. When the knee is at 30 degrees of flexion, the resulting laxity is approximately 2 mm less than the contralateral leg (the "High Tension" treatment). When the tension is performed with the knee in extension (0 degrees of flexion), the the laxity is equal to that of the contralateral leg (the "Low Tension" treatment). Both methods are commonly used in clinical practice. The effect it may have on articular cartilage remains unknown.
0
44
0
44
20
44
EG002
Uninjured Control Group
Uninjured age, sex, and race matched control group