Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
186 participants
Study Classification
INTERVENTIONAL
Study Start Date
1999-01-31
Study Completion Date
2007-08-31
Brief Summary
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The purpose of this trial is to evaluate the effectiveness of arthroscopy (lavage and debridement) in conjunction with the best available non-surgical treatment versus the best available non-surgical treatment alone (medication, health education and physical therapy) in patients with osteoarthritis of the knee.
Detailed Description
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Osteoarthritis is estimated to affect half of the adult population, and by the age of 75 years, it is anticipated that 85 of 100 elderly patients will have some form of this disease. Osteoarthritis (OA) is characterized by moderate to severe pain that limits functional ability. It is suspected that the causes of this debilitating pain include irritation of the synovium, excessive subchondral bone forces and raised intra-arterial pressure. The knee is the most commonly affected weight-bearing joint. Osteoarthritis has a great social impact, as the second most common reason for work disability in the United States. The prevalence of OA is expected to increase in the coming years due to increased longevity, increased proportion of the population over the age of 75 years, and increased diagnostic ability.
Rather than further evaluations of different forms of arthroscopic surgery (ie lavage vs debridement vs abrasion) in the treatment of knee OA, we feel it is important to establish the efficacy of this technology compared to the best non-surgical treatment alone.
This is an evaluator- blinded, phase III, single-centre, group sequential randomized controlled trial in patients with osteoarthritis of the knee.
Treatment effectiveness is based upon patients' disease specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) Osteoarthritis Index. In addition patients' physical function and cost effectiveness are being assessed. Costs will be estimated from the perspectives of the health care system, the patient,family, and society and will include the use of hospital and other resources as well as the economic implications of lost workdays associated with these alternative treatments.
This randomized clinical trial will provide high quality evidence to determine what the role of this expensive treatment is in the overall management of OA.
Rather than further evaluations of different forms of arthroscopic surgery (ie lavage vs debridement vs abrasion) in the treatment of knee OA, we feel it is important to establish the efficacy of this technology compared to the best non-surgical treatment alone.
This is an evaluator- blinded, phase III, single-centre, group sequential randomized controlled trial in patients with osteoarthritis of the knee.
Treatment effectiveness is based upon patients' disease specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) Osteoarthritis Index. In addition patients' physical function and cost effectiveness are being assessed. Costs will be estimated from the perspectives of the health care system, the patient,family, and society and will include the use of hospital and other resources as well as the economic implications of lost workdays associated with these alternative treatments.
This randomized clinical trial will provide high quality evidence to determine what the role of this expensive treatment is in the overall management of OA.
Conditions
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Osteoarthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Arthroscopy plus Medical Management
Arthroscopic Surgery of the Knee plus the optimized medical management including physiotherapy, education, medication, etc
Group Type
ACTIVE_COMPARATOR
Arthroscopy plus Medical Management
Intervention Type
PROCEDURE
Arthroscopic Surgery
Medical Management
Intervention Type
OTHER
education, optimized medication, weight loss where needed, HA or cortisone injections if needed, physiotherapy
Medical Management
Optimized Medical management including physiotherapy, education, medication, etc
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Arthroscopy plus Medical Management
Arthroscopic Surgery
Intervention Type
PROCEDURE
Medical Management
education, optimized medication, weight loss where needed, HA or cortisone injections if needed, physiotherapy
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
1. Idiopathic or secondary osteoarthritis of the knee as diagnosed by Altman et al 2 classification tree -83 percent sensitivity, 93percent specificity
2. Grades 2 to 4 severity of OA by radiographic evaluation- modified Kellgren and Lawrence grading system
3. Age greater than 18.
2. Grades 2 to 4 severity of OA by radiographic evaluation- modified Kellgren and Lawrence grading system
3. Age greater than 18.
Exclusion Criteria
1. Inflammatory or post-infection arthritis of the knee
2. Previous arthroscopy for treatment of knee OA
3. Isolated medial compartment OA Grade 3-4 with greater than 5 degrees mechanical varus -ideal candidate for high tibial osteotomy
4. Isolated lateral compartment OA Grade III-IV with greater than 5 degrees mechanical valgus -ideal candidate for high tibial osteotomy or distal femoral osteotomy
5. Grade 4 OA in at least 2 compartments and over 60 years of age -ideal candidate for total knee arthroplasty
6. Cortico-steroid injection within the last three months.
7. Major neurological deficit
8. Major medical illness -life expectancy less than 2 years or with unacceptably high operative risk.
9. Pregnant
10. Unable to speak or read English
11. Psychiatric illness that limits informed consent
12. Unwilling to be followed for 2 years
2. Previous arthroscopy for treatment of knee OA
3. Isolated medial compartment OA Grade 3-4 with greater than 5 degrees mechanical varus -ideal candidate for high tibial osteotomy
4. Isolated lateral compartment OA Grade III-IV with greater than 5 degrees mechanical valgus -ideal candidate for high tibial osteotomy or distal femoral osteotomy
5. Grade 4 OA in at least 2 compartments and over 60 years of age -ideal candidate for total knee arthroplasty
6. Cortico-steroid injection within the last three months.
7. Major neurological deficit
8. Major medical illness -life expectancy less than 2 years or with unacceptably high operative risk.
9. Pregnant
10. Unable to speak or read English
11. Psychiatric illness that limits informed consent
12. Unwilling to be followed for 2 years
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Sponsor Role
collaborator
Fowler Kennedy Sport Medicine Clinic
OTHER
Sponsor Role
lead
Responsible Party
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Sharon Griffin
Research Coordinator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Peter J Fowler, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Fowler Kennedy Sport Medicine Clinic
Locations
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Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada
Site Status
Countries
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Canada
References
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Altman RD, Fries JF, Bloch DA, Carstens J, Cooke TD, Genant H, Gofton P, Groth H, McShane DJ, Murphy WA, et al. Radiographic assessment of progression in osteoarthritis. Arthritis Rheum. 1987 Nov;30(11):1214-25. doi: 10.1002/art.1780301103.
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Birmingham TB, Primeau CA, Shariff SZ, Reid JNS, Marsh JD, Lam M, Dixon SN, Giffin JR, Willits KR, Litchfield RB, Feagan BG, Fowler PJ. Incidence of Total Knee Arthroplasty After Arthroscopic Surgery for Knee Osteoarthritis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e246578. doi: 10.1001/jamanetworkopen.2024.6578.
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DERIVED
Marsh JD, Birmingham TB, Giffin JR, Isaranuwatchai W, Hoch JS, Feagan BG, Litchfield R, Willits K, Fowler P. Cost-effectiveness analysis of arthroscopic surgery compared with non-operative management for osteoarthritis of the knee. BMJ Open. 2016 Jan 12;6(1):e009949. doi: 10.1136/bmjopen-2015-009949.
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DERIVED
Kirkley A, Birmingham TB, Litchfield RB, Giffin JR, Willits KR, Wong CJ, Feagan BG, Donner A, Griffin SH, D'Ascanio LM, Pope JE, Fowler PJ. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2008 Sep 11;359(11):1097-107. doi: 10.1056/NEJMoa0708333.
Reference Type
DERIVED
Other Identifiers
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CIHR MCT-15227
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FKSMC-CIHR-1
Identifier Type: -
Identifier Source: org_study_id