Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00312533|
Recruitment Status : Completed
First Posted : April 10, 2006
Last Update Posted : August 25, 2008
|Condition or disease||Intervention/treatment|
|Osteoarthritis, Knee||Drug: Hylan F- 20|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312533
|United States, Colorado|
|Steadman Hawkins Clinic|
|Vail, Colorado, United States, 81657|
|Principal Investigator:||John R Steadman, MD||Steadman Hawkins Research Foundation|