NCT00562822.
Methods |
Study design: prospective single‐blind, single‐centre, parallel, two‐arm randomised controlled trial Setting: London Health Sciences Centre ‐ University Hospital, London, Ontario, Canada Trial time period: January 1999 to August 2007 Interventions: arthroscopic surgery plus optimised physical and medical therapy versus optimised physical and medical therapy Sample size calculations: estimated enrolment of 188 participants, no sample size calculations reported Analysis: not reported |
Participants |
Inclusion Criteria Idiopathic or secondary osteoarthritis of the knee with Grade 2 to 4 radiographic severity as defined by the modified Kellgren‐Lawrence classification Exclusion Criteria
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Interventions |
Arthroscopic surgery plus optimised physical and medical therapy: arthroscopic surgery to treat unresolved symptoms of osteoarthritis of the knee Optimised physical and medical therapy: treatment with physical and medical therapy alone |
Outcomes |
Primary outcome measures: Function, pain and quality of life based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores (time frame: 2 years) Secondary outcome measures: Health utility using the standard‐gamble technique (time frame: 24 months) |
Notes |
Clinical trial registration:NCT00562822 Trial status: recruitment completed Estimated study completion date: recruitment completed in August 2007; however, results not available yet |