Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears

Study Overview
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Brief Summary
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This study is conducted as a collaboration between NAR, Orthopedic Department, Oslo University Hospital,Ullevaal, Hjelp24Nimi Oslo, 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
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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. 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 and finally at five years.

Official Title
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The Effect of Arthroscopic Partial Meniscectomy or Exercise Therapy as Treatment of Degenerative Meniscus Tears in Middle-aged Patients. A Randomized, Controlled Trial

Conditions
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Degenerative Meniscal Tear

Intervention / Treatment
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* Procedure: Arthroscopic partial menisectomy
* Other: Supervised neuromuscular and strength training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arthroscopic partial meniscectomy<br>Standard arthroscopic partial meniscectomy - NGD 1 | Procedure: Arthroscopic partial menisectomy<br>* Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital.<br>|
| Experimental: Exercise Therapy<br>Supervised neuromuscular- and strength training | Other: Supervised neuromuscular and strength training<br>* Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) |  | at 2 years | 
| Isokinetic muscle strength tests for knee extensors and flexors |  | at 3 months | 
| Incident and enlarging marginal tibiofemoral osteophyte. |  | At 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 and EQ5D |  | 2 years | 
| Isokinetic muscle strength tests for knee extensors and flexors |  | 2 years | 
| Two one-legged hop tests and maximal number of knee bendings in 30 seconds. |  | 2 years | 
| Two one-legged hop tests and maximal number of knee bendings in 30 seconds. |  | At 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Degenerative meniscal tear, Arthroscopy, Exercise therapy