Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears
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|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||Phase|
|Degenerative Meniscal Tear||Procedure: Arthroscopic partial menisectomy Other: Supervised neuromuscular and strength training||Not Applicable|
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002794
|Orthopaedic Department, Oslo University Hospital, Ullevaal|
|Oslo, Norway, 0407|