Surgery Versus No Surgery for Osteoarthritis (OA) of the Knee

Phase 3

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Procedure: Arthroscopic surgery; Other: Physical and medical therapy

• Registration Number: NCT00562822
• Lead Sponsor: University of Western Ontario, Canada

Brief Summary

The purpose of this study is to discover whether arthroscopic surgery is helpful in controlling the symptoms of osteoarthritis of the knee.

Detailed Description

Although arthroscopic surgery has been widely used for osteoarthritis of the knee, scientific evidence to support its efficacy is lacking. This study will compare optimized physical and medical therapy alone with arthroscopic treatment in addition to optimized physical and medical therapy.

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-22
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-21
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• Idiopathic or secondary osteoarthritis of the knee with Grade II to IV radiographic severity as defined by the modified Kellgren and Lawrence classification

Exclusion Criteria

• Patients with inflammatory or post-infectious arthritis
• Those who had undergone previous arthroscopic treatment for knee osteoarthritis
• Those with isolate Grade III to IV medical compartment osteoarthritis with greater than 5 degrees of varus deformity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthroscopic Surgery	Arthroscopic surgery	Arthroscopic surgery optimized with physical and medical therapy
Arthroscopic Surgery	Physical and medical therapy	Arthroscopic surgery optimized with physical and medical therapy
Physical and medical therapy	Physical and medical therapy	treatment with physical and medical therapy alone

Primary Outcome Measures

Name	Time	Method
Function, pain and quality of life based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores	2 years

Secondary Outcome Measures

Name	Time	Method
Health utility using the Standard Gamble Technique	24 months

Trial Locations

Locations (1)

London Health Sciences Centre - University Hospital; 🇨🇦 London, Ontario, Canada