Surgery Versus no Surgery for OA of the Knee

November 26, 2015 updated by: Sharon Griffin, Fowler Kennedy Sport Medicine Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
SF-36,Mactar, Arthritis Self-Efficacy Scale, Standard Gamble Utility Measure
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fowler Kennedy Sport Medicine Clinic

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (ESTIMATE)

September 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 26, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKSMC-CIHR-1
  • CIHR MCT-15227 (OTHER_GRANT: Canadian Instititute for Health Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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