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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| South-Eastern Norway Regional Health Authority | OTHER |
This study is conducted as a collaboration between NAR, Orthopedic Department, Oslo University Hospital,Ullevaal, Hjelp24Nimi Oslo, Martina Hansens Hospital Norway, and University of Southern Denmark, Odense, Denmark.
The investigators hypothesize that exercise is more effective than arthroscopic partial meniscectomy: a) on self-reported outcomes, functional performance and muscle strength in middle-aged patients subsequent to arthroscopic partial meniscectomy for a degenerative meniscus tear, and b) in preventing further development of knee osteoarthritis (OA).
The aims of the study are:
Patients included in the study will be randomized into one of two groups. The interventions are: arthroscopic partial meniscectomy and supervised neuromuscular- and strength training. Subjects will be tested before and after intervention, at 12 months, 24 months, five and 10 years.
Long-term follow-up studies are particularly important for this patient population. Both meniscal tears and partial meniscectomy has been demonstrated as risk factors for incident knee osteoarthritis and progression. However, it is not known whether the increased risk is due to the meniscal tear per se or resection of the meniscus. Furthermore, patients presenting with symptomatic degenerative meniscal tears have reduced knee muscle strength, which may be an additional risk factor for knee osteoarthritis. While knee muscle weakness has been shown to persist following surgery, the knowledge of long-term changes following surgical and non-surgical interventions for degenerative meniscal tears is limited. Accordingly, long-term between-group differences in muscle strength changes (at 5 and 10 years) and radiographic knee osteoarthritis changes (10 years) will also be investigated
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthroscopic partial meniscectomy | Experimental | Standard arthroscopic partial meniscectomy - NGD 1 |
|
| Exercise Therapy | Experimental | Supervised neuromuscular- and strength training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic partial menisectomy | Procedure | Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital and Martina Hansens Hospital. |
|
| Measure | Description | Time Frame |
|---|---|---|
| KOOS4 - Change From Baseline | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a patient administered questionnaire containing 42 questions in 5 subscales concerning patient´s knee related pain, other knee symptoms, activity of daily life, sport and recreation and quality of life.Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS4 is a composite score of the mean values of four of the five KOOS subscales (KOOS Pain, KOOS Symptoms, KOOS Sport/Rec and KOOS QOL). | 24 months |
| Peak Torque Knee Extension - Change From Baseline | Peak torque knee extension (Newton meter) - Change from baseline | at 3 months |
| Peak Torque Knee Flexion - Change From Baseline | Peak torque knee flexion (Newton meter) - Change from baseline | 3 months |
| Knee Osteoarthritis Incidence | In line with baseline assessment of the tibiofemoral joint, standing radiographs of the tibiofemoral joint is taken bilaterally with a Synaflexer Frame (Synarc Inc) that ensure alignment of the x-ray beam and standardize the placement of the knee in approximately 20 degrees of flexion and 5 degrees of external rotation for an anterior-posterior view. A sagittal view is also taken with the knee in flexion. Kellgren and Lawrence will be used for classification in addition to description of osteophytes and joint Space narrowing (JSN) will be measured. | 5 years |
| Radiographic Progression (the Osteoarthritis Research Society International [OARSI] Atlas) [Time Frame: At 10 Years] | Radiographic progression based on the sum of marginal tibiofemoral osteophyte grades and tibiofemoral joint space narrowing (the Osteoarthritis Research Society International [OARSI] atlas) [Time Frame: At 10 years] |
| Measure | Description | Time Frame |
|---|---|---|
| One Leg Hop Test - Change From Baseline | Change in distance (meters) hopped on the One leg hop test from baseline to three months (higher is better). | 3 months |
| 6 Meter Timed Hop Test - Change From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| May Arna Risberg, PT, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Department, Oslo University Hospital, Ullevaal | Oslo | 0450 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25299520 | Background | Stensrud S, Risberg MA, Roos EM. Effect of exercise therapy compared with arthroscopic surgery on knee muscle strength and functional performance in middle-aged patients with degenerative meniscus tears: a 3-mo follow-up of a randomized controlled trial. Am J Phys Med Rehabil. 2015 Jun;94(6):460-73. doi: 10.1097/PHM.0000000000000209. | |
| 30446783 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arthroscopic Partial Meniscectomy | Standard arthroscopic partial meniscectomy - NGD 1 Arthroscopic partial menisectomy: Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital and Martina Hansens Hospital. |
| FG001 | Exercise Therapy | Supervised neuromuscular- and strength training Supervised neuromuscular and strength training: Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training. Carried out at Nimi Ullevaal Oslo or Gnist trending- og fysioterapi, Baerum |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arthroscopic Partial Meniscectomy | Standard arthroscopic partial meniscectomy - NGD 1 Arthroscopic partial menisectomy: Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital and Martina Hansens Hospital. |
| BG001 | Exercise Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | KOOS4 - Change From Baseline | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a patient administered questionnaire containing 42 questions in 5 subscales concerning patient´s knee related pain, other knee symptoms, activity of daily life, sport and recreation and quality of life.Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS4 is a composite score of the mean values of four of the five KOOS subscales (KOOS Pain, KOOS Symptoms, KOOS Sport/Rec and KOOS QOL). | Posted | Mean | 95% Confidence Interval | units on a scale | 24 months |
|
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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 | Arthroscopic Partial Meniscectomy | Standard arthroscopic partial meniscectomy - NGD 1 Arthroscopic partial menisectomy: Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital and Martina Hansens Hospital. Adverse events related to the surgical procedure; i.e. lung embolus, infection, acute heart attac. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor May Arna Risberg | Oslo University Hospital | +4741312776 | marisb@ous-hf.no |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Supervised neuromuscular and strength training | Other | Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training. Carried out at Nimi Ullevaal Oslo or Gnist trending- og fysioterapi, Baerum |
|
| 10 years |
Change in time (seconds) on the 6 meter timed hop test from baseline to 3 months (lower is better)
| 3 months |
| Knee Bends 30 Sec - Change From Baseline | Change in number of repetitions performed on the Knee bends 30 seconds test from baseline to 3 months (higher is better). | 3 months |
| Peak Torque Knee Extension - Change From Baseline | Change in Peak torque knee extension (Newton meter) from baseline to 12 months (higher is better). | 1 year |
| Peak Torque Knee Flexion - Change From Baseline | Change in Peak torque knee flexion (Newton meter) from baseline to 12 months (higher is better). | 12 months |
| One-leg Hop Test - Change in From Baseline | Change in distance (meters) hopped on the One leg hop test from baseline to 12 months (higher is better). | 12 months |
| 6 Meter Timed Hop Test - Change From Baseline | Change in time (seconds) on the 6 meter timed hop test from baseline to 12 months (lower is better). | 12 months |
| Knee Bends 30 Sec - Change From Baseline | Change in number of repetitions performed on the Knee bends 30 seconds test from baseline to 12 months (higher is better). | 12 months |
| KOOS Pain - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | 24 months |
| KOOS Symptoms - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | 24 months |
| KOOS ADL - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities in Daily Living (ADL) subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale | 24 months |
| KOOS Sport/Rec - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport and recreation (Sport/Rec) subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | 24 months |
| KOOS QOL - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | 24 months |
| SF-36 MCS - Change From Baseline | Change in Short form 36 mental component summary (SF-36 MCS) from baseline to 24 months (range: 0-100; higher is better) | 24 months |
| SF-36 PCS - Change From Baseline | Change in Short form 36 physical component summary (SF-36 PCS) from baseline to 24 months (range: 0-100; higher is better) | 24 months |
| KOOS Pain Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale from baseline to five years (range: 0-100; higher is better). | 5 years |
| KOOS Symptoms Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale from baseline to five years (range: 0-100; higher is better). | 5 years |
| KOOS ADL Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) subscale from baseline to five years (range: 0-100; higher is better). | 5 years |
| KOOS Sport/Rec Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport and Recreation (Sport/Rec) subscale from baseline to five years (range: 0-100; higher is better). | 5 years |
| KOOS QOL Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale from baseline to five years (range: 0-100; higher is better). | 5 years |
| Peak Torque Knee Extension - Change From Baseline | Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to five years (higher is better). | 5 years |
| Peak Torque Knee Flexion - Change From Baseline | Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to five years (higher is better). | 5 years |
| Knee Osteoarthritis Incidence (Kellgren and Lawrence Classification ) | Knee osteoarthritis incidence (Kellgren and Lawrence classification) [ Time Frame: 10 years] | 10 years |
| KOOS4 - Change From Baseline | Change in KOOS4 from baseline to 10 years (range: 0-100; higher is better). KOOS4 is a composite score of the mean values of four of the five Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales (KOOS Pain, KOOS Symptoms, KOOS Sport/Rec and KOOS QOL). | 10 years |
| KOOS Pain Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale from baseline to 10 years (range: 0-100; higher is better). | 10 years |
| KOOS Symptoms Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale from baseline to 10 years (range: 0-100; higher is better). | 10 years |
| KOOS ADL Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) subscale from baseline to 10 years (range: 0-100; higher is better). | 10 years |
| KOOS Sport/Rec Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport and recreation (Sport/Rec) subscale from baseline to five years (range: 0-100; higher is better). | 10 years |
| KOOS QOL Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale from baseline to ten years (range: 0-100; higher is better). | 10 years |
| Peak Torque Knee Flexion - Change From Baseline | Change in body weight (kilograms) normalized Peak torque knee flexion (Newton meter/kg) from baseline to ten years (higher is better). | 10 years |
| Peak Torque Knee Extension - Change From Baseline | Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to 10 years (higher is better). | 10 years |
| Kise NJ, Roos EM, Stensrud S, Engebretsen L, Risberg MA. The 6-m timed hop test is a prognostic factor for outcomes in patients with meniscal tears treated with exercise therapy or arthroscopic partial meniscectomy: a secondary, exploratory analysis of the Odense-Oslo meniscectomy versus exercise (OMEX) trial. Knee Surg Sports Traumatol Arthrosc. 2019 Aug;27(8):2478-2487. doi: 10.1007/s00167-018-5241-7. Epub 2018 Nov 16. |
| 31298923 | Background | Kise NJ, Aga C, Engebretsen L, Roos EM, Tariq R, Risberg MA. Complex Tears, Extrusion, and Larger Excision Are Prognostic Factors for Worse Outcomes 1 and 2 Years After Arthroscopic Partial Meniscectomy for Degenerative Meniscal Tears: A Secondary Explorative Study of the Surgically Treated Group From the Odense-Oslo Meniscectomy Versus Exercise (OMEX) Trial. Am J Sports Med. 2019 Aug;47(10):2402-2411. doi: 10.1177/0363546519858602. Epub 2019 Jul 12. |
| 33971735 | Background | Berg B, Roos EM, Kise NJ, Engebretsen L, Holm I, Risberg MA. On a Trajectory for Success-9 in Every 10 People With a Degenerative Meniscus Tear Have Improved Knee Function Within 2 Years After Treatment: A Secondary Exploratory Analysis of a Randomized Controlled Trial. J Orthop Sports Phys Ther. 2021 Jun;51(6):289-297. doi: 10.2519/jospt.2021.10025. Epub 2021 May 10. |
| 27440192 | Result | Kise NJ, Risberg MA, Stensrud S, Ranstam J, Engebretsen L, Roos EM. Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: randomised controlled trial with two year follow-up. BMJ. 2016 Jul 20;354:i3740. doi: 10.1136/bmj.i3740. |
| 32184135 | Result | Berg B, Roos EM, Englund M, Kise NJ, Tiulpin A, Saarakkala S, Engebretsen L, Eftang CN, Holm I, Risberg MA. Development of osteoarthritis in patients with degenerative meniscal tears treated with exercise therapy or surgery: a randomized controlled trial. Osteoarthritis Cartilage. 2020 Jul;28(7):897-906. doi: 10.1016/j.joca.2020.01.020. Epub 2020 Mar 14. |
| 34151533 | Result | Berg B, Roos EM, Kise NJ, Engebretsen L, Holm I, Risberg MA. Muscle Strength and Osteoarthritis Progression After Surgery or Exercise for Degenerative Meniscal Tears: Secondary Analyses of a Randomized Trial. Arthritis Care Res (Hoboken). 2022 Jan;74(1):70-78. doi: 10.1002/acr.24736. |
| 39326908 | Derived | Berg B, Roos EM, Englund M, Kise NJ, Engebretsen L, Eftang CN, Risberg MA. Arthroscopic partial meniscectomy versus exercise therapy for degenerative meniscal tears: 10-year follow-up of the OMEX randomised controlled trial. Br J Sports Med. 2025 Jan 2;59(2):91-98. doi: 10.1136/bjsports-2024-108644. |
| 30142084 | Derived | Kise NJ, Risberg MA, Stensrud S, Ranstam J, Engebretsen L, Roos EM. Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: randomised controlled trial with two year follow-up. Br J Sports Med. 2016 Dec;50(23):1473-1480. doi: 10.1136/bjsports-2016-i3740rep. |
| 22960783 | Derived | Stensrud S, Roos EM, Risberg MA. A 12-week exercise therapy program in middle-aged patients with degenerative meniscus tears: a case series with 1-year follow-up. J Orthop Sports Phys Ther. 2012 Nov;42(11):919-31. doi: 10.2519/jospt.2012.4165. Epub 2012 Sep 5. |
Supervised neuromuscular- and strength training Supervised neuromuscular and strength training: Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training. Carried out at Nimi Ullevaal Oslo or Gnist trending- og fysioterapi, Baerum |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Exercise Therapy | Supervised neuromuscular- and strength training Supervised neuromuscular and strength training: Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training. Carried out at Nimi Ullevaal Oslo or Gnist trending- og fysioterapi, Baerum |
|
|
|
| Primary | Peak Torque Knee Extension - Change From Baseline | Peak torque knee extension (Newton meter) - Change from baseline | Posted | Mean | 95% Confidence Interval | Newton meter | at 3 months |
|
|
|
| Primary | Peak Torque Knee Flexion - Change From Baseline | Peak torque knee flexion (Newton meter) - Change from baseline | Posted | Mean | 95% Confidence Interval | Newton meter | 3 months |
|
|
|
| Primary | Knee Osteoarthritis Incidence | In line with baseline assessment of the tibiofemoral joint, standing radiographs of the tibiofemoral joint is taken bilaterally with a Synaflexer Frame (Synarc Inc) that ensure alignment of the x-ray beam and standardize the placement of the knee in approximately 20 degrees of flexion and 5 degrees of external rotation for an anterior-posterior view. A sagittal view is also taken with the knee in flexion. Kellgren and Lawrence will be used for classification in addition to description of osteophytes and joint Space narrowing (JSN) will be measured. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Primary | Radiographic Progression (the Osteoarthritis Research Society International [OARSI] Atlas) [Time Frame: At 10 Years] | Radiographic progression based on the sum of marginal tibiofemoral osteophyte grades and tibiofemoral joint space narrowing (the Osteoarthritis Research Society International [OARSI] atlas) [Time Frame: At 10 years] | Not Posted | Dec 2024 | 10 years | Participants |
| Secondary | One Leg Hop Test - Change From Baseline | Change in distance (meters) hopped on the One leg hop test from baseline to three months (higher is better). | Posted | Mean | 95% Confidence Interval | Meters | 3 months |
|
|
|
| Secondary | 6 Meter Timed Hop Test - Change From Baseline | Change in time (seconds) on the 6 meter timed hop test from baseline to 3 months (lower is better) | Posted | Mean | 95% Confidence Interval | Seconds | 3 months |
|
|
|
| Secondary | Knee Bends 30 Sec - Change From Baseline | Change in number of repetitions performed on the Knee bends 30 seconds test from baseline to 3 months (higher is better). | Posted | Mean | 95% Confidence Interval | Number of repetitions | 3 months |
|
|
|
| Secondary | Peak Torque Knee Extension - Change From Baseline | Change in Peak torque knee extension (Newton meter) from baseline to 12 months (higher is better). | Posted | Mean | 95% Confidence Interval | Newton meter | 1 year |
|
|
|
| Secondary | Peak Torque Knee Flexion - Change From Baseline | Change in Peak torque knee flexion (Newton meter) from baseline to 12 months (higher is better). | Posted | Mean | 95% Confidence Interval | Netwon meter | 12 months |
|
|
|
| Secondary | One-leg Hop Test - Change in From Baseline | Change in distance (meters) hopped on the One leg hop test from baseline to 12 months (higher is better). | Posted | Mean | 95% Confidence Interval | Meters | 12 months |
|
|
|
| Secondary | 6 Meter Timed Hop Test - Change From Baseline | Change in time (seconds) on the 6 meter timed hop test from baseline to 12 months (lower is better). | Posted | Mean | 95% Confidence Interval | Seconds | 12 months |
|
|
|
| Secondary | Knee Bends 30 Sec - Change From Baseline | Change in number of repetitions performed on the Knee bends 30 seconds test from baseline to 12 months (higher is better). | Posted | Mean | 95% Confidence Interval | Number of repetitions | 12 months |
|
|
|
| Secondary | KOOS Pain - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 months |
|
|
|
| Secondary | KOOS Symptoms - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 months |
|
|
|
| Secondary | KOOS ADL - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities in Daily Living (ADL) subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale | Posted | Mean | 95% Confidence Interval | units on a scale | 24 months |
|
|
|
| Secondary | KOOS Sport/Rec - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport and recreation (Sport/Rec) subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 months |
|
|
|
| Secondary | KOOS QOL - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 months |
|
|
|
| Secondary | SF-36 MCS - Change From Baseline | Change in Short form 36 mental component summary (SF-36 MCS) from baseline to 24 months (range: 0-100; higher is better) | Posted | Mean | 95% Confidence Interval | units on a scale | 24 months |
|
|
|
| Secondary | SF-36 PCS - Change From Baseline | Change in Short form 36 physical component summary (SF-36 PCS) from baseline to 24 months (range: 0-100; higher is better) | Posted | Mean | 95% Confidence Interval | units on a scale | 24 months |
|
|
|
| Secondary | KOOS Pain Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale from baseline to five years (range: 0-100; higher is better). | Posted | Mean | 95% Confidence Interval | units on a scale | 5 years |
|
|
|
| Secondary | KOOS Symptoms Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale from baseline to five years (range: 0-100; higher is better). | Posted | Mean | 95% Confidence Interval | units on a scale | 5 years |
|
|
|
| Secondary | KOOS ADL Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) subscale from baseline to five years (range: 0-100; higher is better). | Posted | Mean | 95% Confidence Interval | units on a scale | 5 years |
|
|
|
| Secondary | KOOS Sport/Rec Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport and Recreation (Sport/Rec) subscale from baseline to five years (range: 0-100; higher is better). | Posted | Mean | 95% Confidence Interval | units on a scale | 5 years |
|
|
|
| Secondary | KOOS QOL Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale from baseline to five years (range: 0-100; higher is better). | Posted | Mean | 95% Confidence Interval | units on a scale | 5 years |
|
|
|
| Secondary | Peak Torque Knee Extension - Change From Baseline | Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to five years (higher is better). | Posted | Mean | 95% Confidence Interval | Newton meters/kg | 5 years |
|
|
|
| Secondary | Peak Torque Knee Flexion - Change From Baseline | Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to five years (higher is better). | Posted | Mean | 95% Confidence Interval | Newton meters/kg | 5 years |
|
|
|
| Secondary | Knee Osteoarthritis Incidence (Kellgren and Lawrence Classification ) | Knee osteoarthritis incidence (Kellgren and Lawrence classification) [ Time Frame: 10 years] | Not Posted | Dec 2024 | 10 years | Participants |
| Secondary | KOOS4 - Change From Baseline | Change in KOOS4 from baseline to 10 years (range: 0-100; higher is better). KOOS4 is a composite score of the mean values of four of the five Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales (KOOS Pain, KOOS Symptoms, KOOS Sport/Rec and KOOS QOL). | Not Posted | Dec 2024 | 10 years | Participants |
| Secondary | KOOS Pain Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale from baseline to 10 years (range: 0-100; higher is better). | Not Posted | 10 years | Participants |
| Secondary | KOOS Symptoms Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale from baseline to 10 years (range: 0-100; higher is better). | Not Posted | Dec 2024 | 10 years | Participants |
| Secondary | KOOS ADL Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) subscale from baseline to 10 years (range: 0-100; higher is better). | Not Posted | Dec 2024 | 10 years | Participants |
| Secondary | KOOS Sport/Rec Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport and recreation (Sport/Rec) subscale from baseline to five years (range: 0-100; higher is better). | Not Posted | Dec 2024 | 10 years | Participants |
| Secondary | KOOS QOL Subscale - Change From Baseline | Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale from baseline to ten years (range: 0-100; higher is better). | Not Posted | Dec 2024 | 10 years | Participants |
| Secondary | Peak Torque Knee Flexion - Change From Baseline | Change in body weight (kilograms) normalized Peak torque knee flexion (Newton meter/kg) from baseline to ten years (higher is better). | Not Posted | Dec 2024 | 10 years | Participants |
| Secondary | Peak Torque Knee Extension - Change From Baseline | Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to 10 years (higher is better). | Not Posted | Dec 2024 | 10 years | Participants |
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Exercise Therapy | Supervised neuromuscular- and strength training Supervised neuromuscular and strength training: Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training. Carried out at Nimi Ullevaal Oslo or Gnist trending- og fysioterapi, Baerum Adverse events related to the exercise; i.e. heart- og lung disease, trauma | 0 | 70 | 0 | 70 | 0 | 70 |
Not provided
Not provided
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |