Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears

May 30, 2014 updated by: Oslo University Hospital

The Effect of Arthroscopic Partial Meniscectomy or Exercise Therapy as Treatment of Degenerative Meniscus Tears in Middle-aged Patients. A Randomized, Controlled Trial

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Orthopaedic Department, Oslo University Hospital, Ullevaal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ANTICIPATED)

January 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

October 25, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (ESTIMATE)

October 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 30, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NARSDU2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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