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Clinical Trials/NCT00158431
NCT00158431CompletedPhase 3

Arthroscopic Surgery Versus Non-surgical Treatment of Osteoarthritis of the Knee

Fowler Kennedy Sport Medicine Clinic1 site in 1 country186 target enrollmentStarted: January 1, 1999Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
186
Locations
1
Primary Endpoint
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

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Idiopathic or secondary osteoarthritis of the knee as diagnosed by Altman et al 2 classification tree -83 percent sensitivity, 93percent specificity
  • •Grades 2 to 4 severity of OA by radiographic evaluation- modified Kellgren and Lawrence grading system
  • •Age greater than 18.

Exclusion Criteria

  • •Inflammatory or post-infection arthritis of the knee
  • •Previous arthroscopy for treatment of knee OA
  • •Isolated medial compartment OA Grade 3-4 with greater than 5 degrees mechanical varus -ideal candidate for high tibial osteotomy
  • •Isolated lateral compartment OA Grade III-IV with greater than 5 degrees mechanical valgus -ideal candidate for high tibial osteotomy or distal femoral osteotomy
  • •Grade 4 OA in at least 2 compartments and over 60 years of age -ideal candidate for total knee arthroplasty
  • •Cortico-steroid injection within the last three months.
  • •Major neurological deficit
  • •Major medical illness -life expectancy less than 2 years or with unacceptably high operative risk.
  • •Unable to speak or read English
  • •Psychiatric illness that limits informed consent
  • •Unwilling to be followed for 2 years

Arms & Interventions

Arthroscopy plus Medical Management

Active Comparator

Arthroscopic Surgery of the Knee plus the optimized medical management including physiotherapy, education, medication, etc

Intervention: Arthroscopy plus Medical Management (Procedure)

Arthroscopy plus Medical Management

Active Comparator

Arthroscopic Surgery of the Knee plus the optimized medical management including physiotherapy, education, medication, etc

Intervention: Medical Management (Other)

Medical Management

No Intervention

Optimized Medical management including physiotherapy, education, medication, etc

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • SF-36,Mactar, Arthritis Self-Efficacy Scale, Standard Gamble Utility Measure(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sharon Griffin

Research Coordinator

Fowler Kennedy Sport Medicine Clinic

Study Sites (1)

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