Surgery Versus No Surgery for Osteoarthritis (OA) of the Knee (MRC Knee)

May 21, 2014 updated by: University of Western Ontario, Canada

Arthroscopic vs. Non-surgical Treatment of Osteoarthritis of the Knee

The purpose of this study is to discover whether arthroscopic surgery is helpful in controlling the symptoms of osteoarthritis of the knee.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although arthroscopic surgery has been widely used for osteoarthritis of the knee, scientific evidence to support its efficacy is lacking. This study will compare optimized physical and medical therapy alone with arthroscopic treatment in addition to optimized physical and medical therapy.

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Phase 3

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

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre - University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Idiopathic or secondary osteoarthritis of the knee with Grade II to IV radiographic severity as defined by the modified Kellgren and Lawrence classification

Exclusion Criteria:

  • Patients with inflammatory or post-infectious arthritis
  • Those who had undergone previous arthroscopic treatment for knee osteoarthritis
  • Those with isolate Grade III to IV medical compartment osteoarthritis with greater than 5 degrees of varus deformity.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arthroscopic Surgery
Arthroscopic surgery optimized with physical and medical therapy
Procedure: Arthroscopic surgery
Arthroscopic surgery to treat unresolved symptoms of osteoarthritis of the knee
Other: Physical and medical therapy
Treatment with physical and medical therapy alone
Active Comparator: Physical and medical therapy
treatment with physical and medical therapy alone
Other: Physical and medical therapy
Treatment with physical and medical therapy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Function, pain and quality of life based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Health utility using the Standard Gamble Technique
Time Frame: 24 months
24 months

Collaborators and Investigators

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

Sponsor

University of Western Ontario, Canada

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Peter J Fowler, MD, Western University, Canada
  • Study Chair: Brian G Feagan, MD, Western University, Canada

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

January 1, 1999

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimate)

November 22, 2007

Study Record Updates

Last Update Posted (Estimate)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mrc123456
  • MCT-15227

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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