An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
The purpose of this study is to find out if hyaluronan, an injectable medication for knee arthritis, also works for arthritis at the base of the thumb. This study will also evaluate how good ultrasound is at visualizing medication in the thumb joint. We are no longer recruiting for this part of the open label trial.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study|
- The Disabilities of the Arm, Shoulder and Hand Outcome Measure [ Time Frame: 26 weeks (6 months) ] [ Designated as safety issue: No ]The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded.
- Visual Analog Scale for Pain [ Time Frame: 26 weeks (6 months) ] [ Designated as safety issue: No ]The visual analog scale for pain (VAS) is a test requiring a patient to indicate along a line how much pain they are experiencing between 0-100. A score of 100 indicates the maximum possible pain level and a score of 0 indicates no pain. Scores are recorded as whole number integers. The change in VAS (delta) over those 6 months was recorded.
|Study Start Date:||October 2004|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: Pilot Study of Hylan G-F 20
32 Subjects have received Synvisc Injections and followed for 6 months.
Device: Synvisc (hylan G-F20)
32 subjects in the pilot study have received 3 1ml injections of Synvisc intraarticular over the course of 3 weeks and then followed for 6 months post injection
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198029
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Lisa Mandl, MD MPH||Hospital for Special Surgery, New York|