OMEX - (Odense – Oslo Meniscectomy versus Exercise) trial

Study description

 

Degenerative meniscal tears are among the most frequently treated injuries in orthopedic hospitals, and the trend is increasing. However, studies have shown that arthroscopic meniscal resection gives no additional effect upon knee function and pain, in patients treated with exercise therapy in combination with surgery, compared to exercise therapy alone. Additionally, no studies have compared results after isolated surgical treatment or exercise therapy only.

 

The OMEX study is a randomized controlled study, where totally 140 middle aged patients (35-60 years) with MR-verified degenerative medial meniscal tears and Kellgren-Lawrence radiologic degenerative changes stage 0-2, were randomized to treatment with either 12-weeks supervised exercise therapy or arthroscopic partial meniscal resection.

 

The validated self-report questionnaire KOOS (Knee Injury and Osteoarthritis Outcome Score) was filled in before intervention and after 3, 12 and 24 months. KOOS contains 42 items in 5 subscales measuring knee Pain, other Symptoms, knee related ADL (activity of daily living), function in Sport and Recreation and knee-related Quality of life.

 

The main outcome of the 2-year follow-up of the OMEX is difference between the groups in change in KOOS4, a composite of 4 of the 5 subscales, from baseline to the 2-year follow-up. Secondary outcomes are the 5 KOOS subscales, SF-36, global knee rating, muscle strength (@ 1 year) and functional performance (@ 1 year).

 

In a previous published study by our group the exercise therapy program is described in detail, and among the first 20 patients in this RCT randomized to exercise therapy, there was a statistically and clinically significant higher score in all KOOS subscales after 12 weeks therapy, which sustained until 12 months post intervention. Accordingly, the program is shown to be effective in these patients and they tolerated the intervention good, as well.

 

The purpose for the 2-year follow-up is to evaluate long-term effect of treatment of degenerative meniscal tears with either exercise therapy or arthroscopic meniscal resection.

 

Furthermore, a 5-year follow-up is planned and the main outcome will be osteoarthritis related radiologic changes.

 

Statistical analysis plan (SAP)