- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00562822
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
-
-
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
|
Arthroscopic surgery to treat unresolved symptoms of osteoarthritis of the knee
Treatment with physical and medical therapy alone
|
Active Comparator: Physical and medical therapy
treatment with physical and medical therapy alone
|
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.
Collaborators
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.
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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Clinical Trials on Arthroscopic surgery
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Madigan Army Medical CenterCompletedFemoroacetabular ImpingementUnited States
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Royal National Orthopaedic Hospital NHS TrustUniversity of SydneyCompletedAtraumatic Shoulder InstabilityUnited Kingdom
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Fondren Orthopedic Group L.L.P.InGeneron, Inc.CompletedArticular Cartilage Defect Grade III or IV of the KneeUnited States
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University Hospital, GhentWithdrawn
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Smith & Nephew, Inc.TerminatedRotator Cuff InjuriesUnited States, Hong Kong, United Kingdom, France, Singapore, Switzerland, Australia, Canada