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The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.
The purpose of the current investigation is to assess the bone ingrowth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a primary total hip replacement.
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| Measure | Description | Time Frame |
|---|---|---|
| DEXA Analysis of BMD at Preoperative Visit | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. | Preoperative |
| DEXA Analysis of BMD at 3 Months | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. | 3 Months |
| DEXA Analysis of BMD at 6 Months | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. | 6 Months |
| DEXA Analysis of BMD at 1 Year | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Harris Hip Score (HHS) at Preoperative Visit | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. |
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Inclusion Criteria:
Exclusion Criteria:
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The purpose of this investigation is to assess the bone growth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a total hip replacement.
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| Name | Affiliation | Role |
|---|---|---|
| Steve McMahon, MD | Malabar Orthopaedic Clinic | Principal Investigator |
| Beate Hanson, MD, PhD | Vice Presidient, Global Clinical Strategy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malabar Orthopaedic Clinic | Windsor | 3181 | Australia |
A total of 22 subjects were screened, with 20 subjects enrolled and had surgery/MIS implanted.
This study was conducted by 1 investigator in 1 country from 14 Sep 2009 to 18 Apr 2016.
| ID | Title | Description |
|---|---|---|
| FG000 | MIS (Mini Stem) Stem | Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during total hip arthroplasty (THA). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MIS Stem | Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. All subjects had implantation of the MIS femoral stem/modular neck during THA. DEXA was used to assess the bone ingrowth and detect significant alterations in skeletal structure that may not be visible during routine clinical assessment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | DEXA Analysis of BMD at Preoperative Visit | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. | Posted | Mean | Standard Deviation | g/cm^2 | Preoperative |
|
The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MIS Stem | Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Proprietary system | Systematic Assessment | Death from unknown causes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paroxysmal Atrial fibrillation | Cardiac disorders | Proprietary system | Systematic Assessment |
There was a decreased compliance rate at the 3 year follow-up and a 50% termination rate by the 5 year follow-up resulting in a much smaller sample sizes for data collection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracey Brengola | Smith & Nephew | 978-319-2702 | tracey.brengola@smith-nephew.com |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| DEXA Analysis of BMD at 2 Years | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. | 2 Year |
| Preoperative |
| Harris Hip Score (HHS) at 3 Month Visit | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. | 3 Month |
| Harris Hip Score (HHS) at 6 Month Visit | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. | 6 Months |
| Harris Hip Score (HHS) at 1 Year Visit | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. | 1 Year |
| Harris Hip Score (HHS) at 2 Year Visit | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. | 2 Years |
| Harris Hip Score (HHS) at 5 Year Visit | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. | 5 Year |
| Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. | Preoperative |
| Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. | 3 Months |
| Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. | 6 Months |
| Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. | 1 Year |
| Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. | 2 Years |
| Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. | 5 Years |
| Radiographic Assessment at Preoperative Visit (Yes/No Components) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip | Discharge |
| Radiographic Assessment at 3 Month Visit (Yes/No Components) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip | 3 Months |
| Radiographic Assessment at 1 Year Visit (Yes/No Components) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip | 1 Year |
| Radiographic Assessment at 5 Year Visit (Yes/No Components) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip | 5 Year |
| Radiographic Assessment at Discharge Visit | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Discharge |
| Radiographic Assessment at 3 Month Visit | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 3 Months |
| Radiographic Assessment at 1 Year Visit | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 1 Year |
| Radiographic Assessment at 5 Year Visit | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 5 Year |
| Radiographic Assessment at Discharge Visit (Neutral/Valgus Component) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Discharge |
| Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 3 Months |
| Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 1 Year |
| Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | 5 Years |
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Primary Diagnosis Charnley Classification | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | DEXA Analysis of BMD at 3 Months | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. | Posted | Mean | Standard Deviation | g/cm^2 | 3 Months |
|
|
|
| Primary | DEXA Analysis of BMD at 6 Months | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. | Posted | Mean | Standard Deviation | g/cm^2 | 6 Months |
|
|
|
| Primary | DEXA Analysis of BMD at 1 Year | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. | Posted | Mean | Standard Deviation | g/cm^2 | 1 Year |
|
|
|
| Primary | DEXA Analysis of BMD at 2 Years | DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area. | Posted | Mean | Standard Deviation | g/cm^2 | 2 Year |
|
|
|
| Secondary | Baseline Harris Hip Score (HHS) at Preoperative Visit | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. | Posted | Mean | Standard Deviation | score on a scale | Preoperative |
|
|
|
| Secondary | Harris Hip Score (HHS) at 3 Month Visit | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. | Overall number of participants analyzed was 20 particpants; however, for the Function and Total Overall portion of the questionnaire only 18 participants responded. | Posted | Mean | Standard Deviation | score on a scale | 3 Month |
|
|
|
| Secondary | Harris Hip Score (HHS) at 6 Month Visit | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
|
|
|
| Secondary | Harris Hip Score (HHS) at 1 Year Visit | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. | Two subjects were missing results from the study site for the HHS. | Posted | Mean | Standard Deviation | score on a scale | 1 Year |
|
|
|
| Secondary | Harris Hip Score (HHS) at 2 Year Visit | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. | Number of participants returning for this time point visit assessment. | Posted | Mean | Standard Deviation | score on a scale | 2 Years |
|
|
|
| Secondary | Harris Hip Score (HHS) at 5 Year Visit | The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems. | Number of participants returning for this time point visit assessment. | Posted | Mean | Standard Deviation | score on a scale | 5 Year |
|
|
|
| Secondary | Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. | Posted | Mean | Standard Deviation | score on a scale | Preoperative |
|
|
|
| Secondary | Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. | Information was not provided from the study site for two subjects in the HOOS Sports/Recreational Activities (0-100) category. | Posted | Mean | Standard Deviation | score on a scale | 3 Months |
|
|
|
| Secondary | Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. | Information was not provided from the study site for two subjects in the HOOS Sports/Recreational Activities (0-100) category. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
|
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| Secondary | Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. | Number of participants returning for this time point visit assessment. | Posted | Mean | Standard Deviation | score on a scale | 1 Year |
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| Secondary | Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. | Number of participants returning for this time point visit assessment. Information was not provided from the study site for 1 subject in the HOOS Sports/Recreational Activities (0-100) and Quality of Life (0-100) categories. | Posted | Mean | Standard Deviation | score on a scale | 2 Years |
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| Secondary | Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit | The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms. | Information was not provided from the study site for 1 subject in the HOOS Pain (0-100), Daily Living (0-100), Sports/Recreational Activities (0-100), and Quality of Life (0-100) categories. | Posted | Mean | Standard Deviation | score on a scale | 5 Years |
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| Secondary | Radiographic Assessment at Preoperative Visit (Yes/No Components) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip | Posted | Count of Participants | Participants | Discharge |
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| Secondary | Radiographic Assessment at 3 Month Visit (Yes/No Components) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip | Posted | Count of Participants | Participants | 3 Months |
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| Secondary | Radiographic Assessment at 1 Year Visit (Yes/No Components) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip | Posted | Count of Participants | Participants | 1 Year |
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| Secondary | Radiographic Assessment at 5 Year Visit (Yes/No Components) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip | All participants available at this time point visit assessment. | Posted | Count of Participants | Participants | 5 Year |
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| Secondary | Radiographic Assessment at Discharge Visit | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Posted | Mean | Standard Deviation | degree | Discharge |
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| Secondary | Radiographic Assessment at 3 Month Visit | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Posted | Mean | Standard Deviation | degree | 3 Months |
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| Secondary | Radiographic Assessment at 1 Year Visit | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Posted | Mean | Standard Deviation | degree | 1 Year |
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| Secondary | Radiographic Assessment at 5 Year Visit | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | All available subjects participating in this time point visit assessment. | Posted | Mean | Standard Deviation | degree | 5 Year |
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| Secondary | Radiographic Assessment at Discharge Visit (Neutral/Valgus Component) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Posted | Count of Participants | Participants | Discharge |
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| Secondary | Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Posted | Count of Participants | Participants | 3 Months |
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| Secondary | Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | Posted | Count of Participants | Participants | 1 Year |
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| Secondary | Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component) | Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. | All available subjects participating in this time point visit assessment. | Posted | Count of Participants | Participants | 5 Years |
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| 2 |
| 20 |
| 13 |
| 20 |
| 14 |
| 20 |
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| Atrial fibrillation | Congenital, familial and genetic disorders | Proprietary system | Systematic Assessment |
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| Cut hand - hospital admission for intervenous (IV) antibiotics | Injury, poisoning and procedural complications | Proprietary system | Systematic Assessment |
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| Contralateral THR secondary to osteoarthritis (OA) | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
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| Unicompartmental knee replacement secondary to OA | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
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| Cholecystectomy | Gastrointestinal disorders | Proprietary system | Systematic Assessment |
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| Alzheimer's Disease | Nervous system disorders | Proprietary system | Systematic Assessment |
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| Subsidence of femoral prosthesis; revision in THR | Product Issues | Propietary system | Systematic Assessment |
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| Dislocation THR | Product Issues | Proprietary system | Systematic Assessment |
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| Bleeding gastric ulcer | Gastrointestinal disorders | Proprietary system | Systematic Assessment |
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| Osteolysis region 1, 3-7 on radiograph | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
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| Pain on weight-bearing lower thigh | Injury, poisoning and procedural complications | Proprietary system | Systematic Assessment |
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| Cortical thickening region 3 | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
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| Newly diagnosed hypoparathyroidism | Metabolism and nutrition disorders | Proprietary system | Systematic Assessment |
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| Mild sclerosis over weight-bearing aspect of acetabulum on x-ray | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
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| Adductor tendonitis | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
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| Hip pain | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
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| Sprained Adductors | Injury, poisoning and procedural complications | Propietary system | Systematic Assessment |
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| Thigh and trochanteric pain | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
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| Condensation around tip of stem on x-ray femur | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
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| Trochanteric pain | Musculoskeletal and connective tissue disorders | Proprietary system | Systematic Assessment |
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Not provided
| D012216 |
| Rheumatic Diseases |
| Title | Measurements |
|---|---|
|
| Femoral Region 4 |
|
| Femoral Region 5 |
|
| Femoral Region 6 |
|
| Femoral Region 7 |
|
| Title | Measurements |
|---|---|
|
| Femoral Region 4 |
|
| Femoral Region 5 |
|
| Femoral Region 6 |
|
| Femoral Region 7 |
|
| Title | Measurements |
|---|---|
|
| Femoral Region 4 |
|
| Femoral Region 5 |
|
| Femoral Region 6 |
|
| Femoral Region 7 |
|
| Title | Measurements |
|---|---|
|
| Femoral Region 4 |
|
| Femoral Region 5 |
|
| Femoral Region 6 |
|
| Femoral Region 7 |
|
| Title | Measurements |
|---|---|
|
| Range of Motion |
|
| Total |
|
|
| Absence of Deformity |
|
|
| Range of Motion |
|
|
| Total |
|
|
| Title | Measurements |
|---|---|
|
| Range of Motion |
|
| Total |
|
|
| Absence of Deformity |
|
|
| Range of Motion |
|
|
| Total |
|
|
| Title | Measurements |
|---|---|
|
| Range of Motion |
|
| Total |
|
| Title | Measurements |
|---|---|
|
| Range of Motion |
|
| Total |
|
| Title | Measurements |
|---|---|
|
| Sports/Recreational Activities |
|
| Quality of Life |
|
|
| Daily Living |
|
|
| Sports/Recreational Activities |
|
|
| Quality of Life |
|
|
|
| Daily Living |
|
|
| Sports/Recreational Activities |
|
|
| Quality of Life |
|
|
| Title | Measurements |
|---|---|
|
| Sports/Recreational Activities |
|
| Quality of Life |
|
|
| Daily Living |
|
|
| Sports/Recreational Activities |
|
|
| Quality of Life |
|
|
|
| Daily Living |
|
|
| Sports/Recreational Activities |
|
|
| Quality of Life |
|
|
| No |
|
| Stem Subsidence |
|
| Evidence of Acetabular Component Failure |
|
| Evidence of Femoral Component Failure |
|
| Brooker Classification |
|
| No |
|
| Stem Subsidence |
|
| Evidence of Acetabular Component Failure |
|
| Evidence of Femoral Component Failure |
|
| Brooker Classification |
|
| No |
|
| Stem Subsidence |
|
| Evidence of Acetabular Component Failure |
|
| Evidence of Femoral Component Failure |
|
| Brooker Classification |
|
| No |
|
| Stem Subsidence |
|
| Evidence of Acetabular Component Failure |
|
| Evidence of Femoral Component Failure |
|
| Brooker Classification |
|
|