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

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ClinicalTrials.gov Identifier: NCT00562822
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : May 22, 2014
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Western Ontario, Canada

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

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

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  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Arthroscopic vs. Non-surgical Treatment of Osteoarthritis of the Knee
Study Start Date : January 1999
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. Health utility using the Standard Gamble Technique [ Time Frame: 24 months ]


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.

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

Publications:
Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT00562822     History of Changes
Other Study ID Numbers: mrc123456
MCT-15227
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

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