Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears
|ClinicalTrials.gov Identifier: NCT01002794|
Recruitment Status : Unknown
Verified May 2014 by Oslo University Hospital.
Recruitment status was: Active, not recruiting
First Posted : October 27, 2009
Last Update Posted : June 2, 2014
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).
|Condition or disease||Intervention/treatment|
|Degenerative Meniscal Tear||Procedure: Arthroscopic partial menisectomy Other: Supervised neuromuscular and strength training|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: Arthroscopic partial meniscectomy
Standard arthroscopic partial meniscectomy - NGD 1
Procedure: Arthroscopic partial menisectomy
Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital.
Experimental: Exercise Therapy
Supervised neuromuscular- and strength training
Other: Supervised neuromuscular and strength training
Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: at 2 years ]
- Isokinetic muscle strength tests for knee extensors and flexors [ Time Frame: at 3 months ]
- Incident and enlarging marginal tibiofemoral osteophyte. [ Time Frame: At 5 years ]
- SF-36 and EQ5D [ Time Frame: 2 years ]
- Isokinetic muscle strength tests for knee extensors and flexors [ Time Frame: 2 years ]
- Two one-legged hop tests and maximal number of knee bendings in 30 seconds. [ Time Frame: 2 years ]
- Two one-legged hop tests and maximal number of knee bendings in 30 seconds. [ Time Frame: At 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002794
|Orthopaedic Department, Oslo University Hospital, Ullevaal|
|Oslo, Norway, 0407|