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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT00562822
First received: November 20, 2007
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Osteoarthritis of the Knee
Procedure: Arthroscopic surgery
Other: Physical and medical therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Arthroscopic vs. Non-surgical Treatment of Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • Function, pain and quality of life based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health utility using the Standard Gamble Technique [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 188
Study Start Date: January 1999
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562822

Locations
Canada, Ontario
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
University of Western Ontario, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Peter J Fowler, MD University of Western Ontario, Canada
Study Chair: Brian G Feagan, MD University of Western Ontario, Canada
  More Information

Publications:
Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT00562822     History of Changes
Other Study ID Numbers: mrc123456, MCT-15227
Study First Received: November 20, 2007
Last Updated: May 21, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 21, 2014