Surgery Versus No Surgery for Osteoarthritis (OA) of the Knee (MRC Knee)
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Arthroscopic surgery
Physical and medical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee
Eligibility 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.
Sites / Locations
- London Health Sciences Centre - University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arthroscopic Surgery
Physical and medical therapy
Arm Description
Arthroscopic surgery optimized with physical and medical therapy
treatment with physical and medical therapy alone
Outcomes
Primary Outcome Measures
Function, pain and quality of life based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores
Secondary Outcome Measures
Health utility using the Standard Gamble Technique
Full Information
NCT ID
NCT00562822
First Posted
November 20, 2007
Last Updated
May 21, 2014
Sponsor
University of Western Ontario, Canada
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT00562822
Brief Title
Surgery Versus No Surgery for Osteoarthritis (OA) of the Knee
Acronym
MRC Knee
Official Title
Arthroscopic vs. Non-surgical Treatment of Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Western Ontario, Canada
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to discover whether arthroscopic surgery is helpful in controlling the symptoms of osteoarthritis of the knee.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arthroscopic Surgery
Arm Type
Active Comparator
Arm Description
Arthroscopic surgery optimized with physical and medical therapy
Arm Title
Physical and medical therapy
Arm Type
Active Comparator
Arm Description
treatment with physical and medical therapy alone
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic surgery
Intervention Description
Arthroscopic surgery to treat unresolved symptoms of osteoarthritis of the knee
Intervention Type
Other
Intervention Name(s)
Physical and medical therapy
Intervention Description
Treatment with physical and medical therapy alone
Primary Outcome Measure Information:
Title
Function, pain and quality of life based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Health utility using the Standard Gamble Technique
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Fowler, MD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian G Feagan, MD
Organizational Affiliation
Western University, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
12110735
Citation
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. doi: 10.1056/NEJMoa013259.
Results Reference
background
Learn more about this trial
Surgery Versus No Surgery for Osteoarthritis (OA) of the Knee
We'll reach out to this number within 24 hrs