Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears (OMEX)
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About
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).
Full 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.
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- 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
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
140 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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