Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears

Sponsor

Oslo University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01002794

Collaborator

University of Southern Denmark (Other)

140

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Degenerative Meniscal Tear	Procedure: Arthroscopic partial menisectomy Other: Supervised neuromuscular and strength training	N/A

Detailed 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.

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 Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 :

Nov 1, 2009

Anticipated Primary Completion Date :

Jan 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Knee Injury and Osteoarthritis Outcome Score (KOOS) [at 2 years]
Isokinetic muscle strength tests for knee extensors and flexors [at 3 months]
Incident and enlarging marginal tibiofemoral osteophyte. [At 5 years]

Secondary Outcome Measures

SF-36 and EQ5D [2 years]
Isokinetic muscle strength tests for knee extensors and flexors [2 years]
Two one-legged hop tests and maximal number of knee bendings in 30 seconds. [2 years]
Two one-legged hop tests and maximal number of knee bendings in 30 seconds. [At 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orthopaedic Department, Oslo University Hospital, Ullevaal	Oslo		Norway	0407

Sponsors and Collaborators

Oslo University Hospital
University of Southern Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT01002794

Other Study ID Numbers:

NARSDU2009

First Posted:

Oct 27, 2009

Last Update Posted:

Jun 2, 2014

Last Verified:

May 1, 2014

Keywords provided by Oslo University Hospital

Degenerative meniscal tear

Arthroscopy

Exercise therapy

Study Results

No Results Posted as of Jun 2, 2014