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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00562822
Other study ID # mrc123456
Secondary ID MCT-15227
Status Completed
Phase Phase 3
First received November 20, 2007
Last updated May 21, 2014
Start date January 1999
Est. completion date August 2007

Study information

Verified date May 2014
Source University of Western Ontario, Canada
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Canada London Health Sciences Centre - University Hospital London Ontario

Sponsors (2)

Lead Sponsor Collaborator
University of Western Ontario, Canada Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Function, pain and quality of life based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores 2 years No
Secondary Health utility using the Standard Gamble Technique 24 months No
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