Degenerative Meniscal TearOMEXNCT01002794
Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears
A study testing Arthroscopic partial menisectomy and Supervised neuromuscular and strength training in people with Degenerative Meniscal Tear, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Degenerative Meniscal Tear
- What is being tested?
- Arthroscopic partial menisectomy and Supervised neuromuscular and strength training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2009to Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 35-60 years
- Knee pain for more than 2 months without a significant trauma
- Medial meniscal tear on MRI
- Eligible for arthroscopic partial meniscectomy
- Grade 0-2 radiographic severity (specification after Kellgren Lawrence)
Who cannot join
- Those requiring acute trauma surgeries, including those treated as acute cases in the ER
- Ligament injuries
- Tumours (MRI)
- Pain or other musculoskeletal comorbidities severely affecting lower extremity muscle function overriding the symptoms from the knee
- Grade 3 or 4 radiographic severity (specification after Kellgren Lawrence)
- Comorbidities excluding physical activities and exercise.
- Previous knee surgery within two years
- Not able to speak or read Norwegian, drug abuse or mental problems
Trial locations and contacts
1 site in 1 country.
Norway1 site
Orthopaedic Department, Oslo University Hospital, Ullevaal
Oslo, 0450
About this study
Official title: The Effect of Arthroscopic Partial Meniscectomy or Exercise Therapy as Treatment of Degenerative Meniscus Tears in Middle-aged Patients. A Randomized, Controlled Trial
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).
Read the detailed description
The aims of the study are:
- At 3 months, to investigate the effect of arthroscopic partial meniscectomy versus exercise therapy on muscle strength and knee function in middle-aged patients with degenerative meniscus lesions.
- At 2 years, to investigate the effect of arthroscopic partial meniscectomy versus exercise therapy on self-reported outcomes in middle aged patients with degenerative meniscus lesions.
- At 5 years, to describe radiographic changes in knee osteoarthritis development after arthroscopic partial meniscectomy or exercise therapy in middle-aged patients with degenerative meniscus lesions.
- 4. At 10 years, to describe radiographic changes in knee osteoarthritis development after arthroscopic partial meniscectomy or exercise therapy in middle-aged patients with degenerative meniscus lesions.
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
- Conditions
- Degenerative Meniscal Tear
- Being tested
- Arthroscopic partial menisectomy, Supervised neuromuscular and strength training
- Keywords
- Degenerative meniscal tear, Arthroscopy, Exercise therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic partial menisectomyProcedure or surgery
Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital and Martina Hansens Hospital.
Supervised neuromuscular and strength trainingOther
Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training. Carried out at Nimi Ullevaal Oslo or Gnist trending- og fysioterapi, Baerum
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic partial meniscectomy | Experimental | Standard arthroscopic partial meniscectomy - NGD 1 Receives: Procedure: Arthroscopic partial menisectomy |
| Exercise Therapy | Experimental | Supervised neuromuscular- and strength training Receives: Other: Supervised neuromuscular and strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 months
Peak Torque Knee Extension - Change From Baseline
Peak torque knee extension (Newton meter) - Change from baseline
Measured: at 3 months
Peak Torque Knee Flexion - Change From Baseline
Peak torque knee flexion (Newton meter) - Change from baseline
Measured: 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.
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]
Measured: 10 years
Secondary outcomes (31)
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).
Measured: 3 months
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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 5 years
Knee Osteoarthritis Incidence (Kellgren and Lawrence Classification )
Knee osteoarthritis incidence (Kellgren and Lawrence classification) [ Time Frame: 10 years]
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2016
- Study completionJan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Degenerative Meniscal TearStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, May Arna Risberg, Oslo University Hospital
- Investigators
- May Arna Risberg, PT, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002794
- Sponsor's protocol ID
- NARSDU2009
- Acronym
- OMEX
- Status last verified
- Feb 2024
- First submitted
- 25 Oct 2009
- Last updated
- 29 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
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.
PubMed 25299520Kise 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.
PubMed 30446783Kise 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.
PubMed 31298923Berg 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.
PubMed 33971735Kise 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.
PubMed 27440192Berg 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.
PubMed 32184135Berg 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.
PubMed 34151533Berg 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.
PubMed 39326908Kise 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.
PubMed 30142084Stensrud 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.
PubMed 22960783
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Arthroscopic Partial Meniscectomy or Exercise Therapy as Treatment of Degenerative Meniscus Tears in Middle-aged Patients. A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01002794
- Acronym / sponsor ID
- OMEX / NARSDU2009
- Conditions
- Degenerative Meniscal Tear
- Keywords
- Degenerative meniscal tear, Arthroscopy, Exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, South-Eastern Norway Regional Health Authority
- Study start
- Nov 2009 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jan 2024 (actual)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The aims of the study are:
- At 3 months, to investigate the effect of arthroscopic partial meniscectomy versus exercise therapy on muscle strength and knee function in middle-aged patients with degenerative meniscus lesions.
- At 2 years, to investigate the effect of arthroscopic partial meniscectomy versus exercise therapy on self-reported outcomes in middle aged patients with degenerative meniscus lesions.
- At 5 years, to describe radiographic changes in knee osteoarthritis development after arthroscopic partial meniscectomy or exercise therapy in middle-aged patients with degenerative meniscus lesions.
- 4. At 10 years, to describe radiographic changes in knee osteoarthritis development after arthroscopic partial meniscectomy or exercise therapy in middle-aged patients with degenerative meniscus lesions.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic partial meniscectomy | Experimental | Procedure: Arthroscopic partial menisectomyStandard arthroscopic partial meniscectomy - NGD 1 |
| Exercise Therapy | Experimental | Other: Supervised neuromuscular and strength trainingSupervised neuromuscular- and strength training |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 35-60 years
- Knee pain for more than 2 months without a significant trauma
- Medial meniscal tear on MRI
- Eligible for arthroscopic partial meniscectomy
- Grade 0-2 radiographic severity (specification after Kellgren Lawrence)
Key exclusion criteria (8 listed)
- Those requiring acute trauma surgeries, including those treated as acute cases in the ER
- Ligament injuries
- Tumours (MRI)
- Pain or other musculoskeletal comorbidities severely affecting lower extremity muscle function overriding the symptoms from the knee
- Grade 3 or 4 radiographic severity (specification after Kellgren Lawrence)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic partial menisectomyStandard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital and Martina Hansens Hospital. | Procedure or surgery | Arthroscopic partial meniscectomy |
| Supervised neuromuscular and strength trainingSupervised exercise therapy in 12 weeks, both neuromuscular- and strength training. Carried out at Nimi Ullevaal Oslo or Gnist trending- og fysioterapi, Baerum | Other | Exercise Therapy |
Primary outcome
KOOS4 - Change From Baseline
Time frame: 24 months
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).
Peak Torque Knee Extension - Change From Baseline
Time frame: at 3 months
Peak torque knee extension (Newton meter) - Change from baseline
Peak Torque Knee Flexion - Change From Baseline
Time frame: 3 months
Peak torque knee flexion (Newton meter) - Change from baseline
Knee Osteoarthritis Incidence
Time frame: 5 years
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.
Radiographic Progression (the Osteoarthritis Research Society International [OARSI] Atlas) [Time Frame: At 10 Years]
Time frame: 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]
31 secondary outcomes
One Leg Hop Test - Change From Baseline
Time frame: 3 months
6 Meter Timed Hop Test - Change From Baseline
Time frame: 3 months
Knee Bends 30 Sec - Change From Baseline
Time frame: 3 months
Peak Torque Knee Extension - Change From Baseline
Time frame: 1 year
Peak Torque Knee Flexion - Change From Baseline
Time frame: 12 months
One-leg Hop Test - Change in From Baseline
Time frame: 12 months
6 Meter Timed Hop Test - Change From Baseline
Time frame: 12 months
Knee Bends 30 Sec - Change From Baseline
Time frame: 12 months
KOOS Pain - Change From Baseline
Time frame: 24 months
KOOS Symptoms - Change From Baseline
Time frame: 24 months
KOOS ADL - Change From Baseline
Time frame: 24 months
KOOS Sport/Rec - Change From Baseline
Time frame: 24 months
KOOS QOL - Change From Baseline
Time frame: 24 months
SF-36 MCS - Change From Baseline
Time frame: 24 months
SF-36 PCS - Change From Baseline
Time frame: 24 months
KOOS Pain Subscale - Change From Baseline
Time frame: 5 years
KOOS Symptoms Subscale - Change From Baseline
Time frame: 5 years
KOOS ADL Subscale - Change From Baseline
Time frame: 5 years
KOOS Sport/Rec Subscale - Change From Baseline
Time frame: 5 years
KOOS QOL Subscale - Change From Baseline
Time frame: 5 years
Peak Torque Knee Extension - Change From Baseline
Time frame: 5 years
Peak Torque Knee Flexion - Change From Baseline
Time frame: 5 years
Knee Osteoarthritis Incidence (Kellgren and Lawrence Classification )
Time frame: 10 years
KOOS4 - Change From Baseline
Time frame: 10 years
KOOS Pain Subscale - Change From Baseline
Time frame: 10 years
KOOS Symptoms Subscale - Change From Baseline
Time frame: 10 years
KOOS ADL Subscale - Change From Baseline
Time frame: 10 years
KOOS Sport/Rec Subscale - Change From Baseline
Time frame: 10 years
KOOS QOL Subscale - Change From Baseline
Time frame: 10 years
Peak Torque Knee Flexion - Change From Baseline
Time frame: 10 years
Peak Torque Knee Extension - Change From Baseline
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25299520Stensrud 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.
- Background: PubMed 30446783Kise 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.
- Background: PubMed 31298923Kise 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.
- Background: PubMed 33971735Berg 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.
- Results publication: PubMed 27440192Kise 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.
- Results publication: PubMed 32184135Berg 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.
- Results publication: PubMed 34151533Berg 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.
- Derived from this study: PubMed 39326908Berg 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.
- Derived from this study: PubMed 30142084Kise 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.
- Derived from this study: PubMed 22960783Stensrud 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
May Arna Risberg, PT, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic partial menisectomy and Supervised neuromuscular and strength training in people with Degenerative Meniscal Tear, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS4 - Change From Baseline (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01002794, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.