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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00562822
First Posted: November 22, 2007
Last Update Posted: May 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Western Ontario, Canada
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]

Secondary Outcome Measures:
  • Health utility using the Standard Gamble Technique [ Time Frame: 24 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 20, 2007
First Posted: November 22, 2007
Last Update Posted: May 22, 2014
Last Verified: May 2014

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