Surgery Versus no Surgery for OA of the Knee

NCT00158431 | Completed Phase 3 DMC

• 2 other identifiers: FKSMC-CIHR-1CIHR MCT-15227
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

osteoarthritis; randomized trial; knee; quality of life

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• SF-36,Mactar, Arthritis Self-Efficacy Scale, Standard Gamble Utility Measure

  2 years

Study Arms (2)

Arthroscopy plus Medical Management

ACTIVE COMPARATOR

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

Procedure: Arthroscopy plus Medical Management; Other: Medical Management

Medical Management

NO INTERVENTION

Optimized Medical management including physiotherapy, education, medication, etc

Interventions

Arthroscopy plus Medical Management PROCEDURE

Arthroscopic Surgery

Arthroscopy plus Medical Management

Medical Management OTHER

education, optimized medication, weight loss where needed, HA or cortisone injections if needed, physiotherapy

Arthroscopy plus Medical Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

Related Publications (54)

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MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroscopy; Practice Management, Medical

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Peter J Fowler, MD, FRCSC

  Fowler Kennedy Sport Medicine Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 1999
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

CA (1)