An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
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|ClinicalTrials.gov Identifier: NCT00198029|
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : June 10, 2013
Last Update Posted : April 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carpometacarpal Osteoarthritis||Device: Synvisc (hylan G-F20)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
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
- The Disabilities of the Arm, Shoulder and Hand Outcome Measure [ Time Frame: 26 weeks (6 months) ]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) ]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.
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): 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|