Surgery Versus no Surgery for OA of the Knee

• Sponsor: Fowler Kennedy Sport Medicine Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00158431
• Collaborator: Canadian Institutes of Health Research (CIHR) (Other)
• Enrollment: 186
• Location: 1
• Arms: 2
• Duration (Months): 103
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Procedure: Arthroscopy plus Medical Management; Other: Medical Management	Phase 3

Detailed Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 186 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Arthroscopic Surgery Versus Non-surgical Treatment of Osteoarthritis of the Knee
• Study Start Date: Jan 1, 1999
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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 Surgery; Other: 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

Outcome Measures

Primary Outcome Measures

1. 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 [2 years]

Secondary Outcome Measures

1. SF-36,Mactar, Arthritis Self-Efficacy Scale, Standard Gamble Utility Measure [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fowler Kennedy Sport Medicine Clinic	London	Ontario	Canada	N6A 3K7

Sponsors and Collaborators

• Fowler Kennedy Sport Medicine Clinic
• Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: Peter J Fowler, MD, FRCSC, Fowler Kennedy Sport Medicine Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Sharon Griffin, Research Coordinator, Fowler Kennedy Sport Medicine Clinic
• ClinicalTrials.gov Identifier: NCT00158431
• Other Study ID Numbers: FKSMC-CIHR-1; CIHR MCT-15227
• First Posted: Sep 12, 2005
• Last Update Posted: Nov 30, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Sharon Griffin, Research Coordinator, Fowler Kennedy Sport Medicine Clinic: osteoarthritis; randomized trial; knee; quality of life
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Nov 30, 2015