Overview

This trial is active, not recruiting.

Condition degenerative meniscal tear
Treatments arthroscopic partial menisectomy, supervised neuromuscular and strength training
Sponsor Oslo University Hospital
Collaborator University of Southern Denmark
Start date November 2009
End date January 2015
Trial size 140 participants
Trial identifier NCT01002794, NARSDU2009

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Standard arthroscopic partial meniscectomy - NGD 1
arthroscopic partial menisectomy
Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital.
(Experimental)
Supervised neuromuscular- and strength training
supervised neuromuscular and strength training
Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 35 years up to 60 years old.

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

Additional Information

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
Description The aims of the study are: 1. 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. 2. 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. 3. 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Oslo University Hospital.