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Completed

NCT Number: NCT00158431

Surgery Versus no Surgery for OA 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopy plus Medical Management

Procedure

Arthroscopic Surgery

Medical management

Other

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

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

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Fowler Kennedy Sport Medicine Clinic

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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