Surgery Versus no Surgery for OA of the Knee
|ClinicalTrials.gov Identifier: NCT00158431|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Procedure: Arthroscopy plus Medical Management Other: Medical Management||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Arthroscopic Surgery Versus 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|
Active Comparator: Arthroscopy plus Medical Management
Arthroscopic Surgery of the Knee plus the optimized medical management including physiotherapy, education, medication, etc
Procedure: Arthroscopy plus Medical Management
Arthroscopic SurgeryOther: Medical Management
education, optimized medication, weight loss where needed, HA or cortisone injections if needed, physiotherapy
No Intervention: Medical Management
Optimized Medical management including physiotherapy, education, medication, etc
- To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and [ Time Frame: 2 years ]
- SF-36,Mactar, Arthritis Self-Efficacy Scale, Standard Gamble Utility Measure [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158431
|Fowler Kennedy Sport Medicine Clinic|
|London, Ontario, Canada, N6A 3K7|
|Principal Investigator:||Peter J Fowler, MD, FRCSC||Fowler Kennedy Sport Medicine Clinic|