Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee
The goal of viscosupplementation is to replenish synovial fluid, which will improve patient symptoms and mobility. Viscosupplementation of the knee with hyaluronic acid injections has been shown to improve symptoms in patients with osteoarthritis. Recent studies have shown that this improvement may be highly variable based on the time from treatment, especially in the first 12 weeks following treatment. The purpose of this study is to document the outcomes following a treatment protocol in which corticosteroid is used in addition to the initial Synvisc injection in the series of three injections.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee|
|Study Start Date:||April 2006|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Upon initial visit, all study patients will complete an informed consent. After consent, patients will complete the baseline questionnaire packet, which includes a questionnaire with several validated scoring systems. Following injection, patients will receive a diary to document any adverse events between the first and second injection. In one week, patients will return for a second visit to receive the second injection. Again they will be asked to maintain their diary of adverse events following the second injection. The patient will then receive the final injection at week 3 and will again complete a diary of events for one week. At 1 week, 3 weeks, 6 weeks, 12 weeks, and 26 weeks following the completed series of injections, the patients will complete a form that will include the pain, stiffness, and physical function subscales of the WOMAC score and a 10 point patient satisfaction question.
At 6 months, the patients will receive by mail the same questionnaire packet they received at baseline, with the addition of patient satisfaction and subsequent injury/treatment questions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312533
|United States, Colorado|
|Steadman Hawkins Clinic|
|Vail, Colorado, United States, 81657|
|Principal Investigator:||John R Steadman, MD||Steadman Hawkins Research Foundation|