Surgery Versus no Surgery for OA of the Knee - Full Text View

Sponsors and Collaborators:	Fowler Kennedy Sport Medicine Clinic CIHR
Information provided by:	Fowler Kennedy Sport Medicine Clinic
ClinicalTrials.gov Identifier:	NCT00158431

Sponsors and Collaborators:

Fowler Kennedy Sport Medicine Clinic
CIHR

Information provided by:

Fowler Kennedy Sport Medicine Clinic

ClinicalTrials.gov Identifier:

NCT00158431

Purpose

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	Intervention	Phase
Osteoarthritis	Procedure: Arthroscopic Surgery of the Knee Procedure: the best available non-surgical treatment alone	Phase III

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Arthroscopic Surgery Versus Non-Surgical Treatment of Osteoarthritis of the Knee

Further study details as provided by Fowler Kennedy Sport Medicine Clinic:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SF-36,Mactar, Arthritis Self-Efficacy Scale, Standard Gamble Utility Measure [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	186
Study Start Date:	January 1999
Study Completion Date:	August 2007

Arms	Assigned Interventions
1: Active Comparator Arthroscopic Surgery of the Knee plus the optimized medical management	Procedure: Arthroscopic Surgery of the Knee Arthroscopic Surgery
2: No Intervention Optimized Medical management	Procedure: the best available non-surgical treatment alone education, optimized medication, weight loss where needed, HA or cortisone injections if needed, physiotherapy

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.
Pregnant
Unable to speak or read English
Psychiatric illness that limits informed consent
Unwilling to be followed for 2 years

Responsible Party:	Fowler Kennedy Sport Medicine Clinic ( Peter Fowler )
Study ID Numbers:	FKSMC-CIHR-1, CIHR MCT-15227
Study First Received:	September 7, 2005
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00158431
Health Authority:	Canada: Health Canada

Canada, Ontario
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada, N6A 3K7