Status:
COMPLETED
An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
Genzyme, a Sanofi Company
National Institutes of Health (NIH)
Conditions:
Carpometacarpal Osteoarthritis
Eligibility:
All Genders
45-95 years
Phase:
NA
Brief Summary
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 ultrasoun...
Eligibility Criteria
Inclusion
- Radiographic evidence of at least moderate narrowing (joint space \< 1mm) or the presence of osteophytes or sclerosis at the Carpometacarpal joint
- Patient complaint of unacceptable pain despite modification of activity, a trial of splinting and a therapeutic dose of NSAIDS
- If bilateral disease, only the most severely involved hand, (as defined by VAS for pain), will be entered in the study.
- Proficiency in English.
Exclusion
- Previous bad injury to the thumb
- Previous hand surgery on the study thumb
- Known hand comorbidities (i.e. carpal tunnel syndrome, de Quervains Tenosynovitis etc)
- Rheumatoid arthritis or lupus
- Bleeding problems
- Being on blood thinners (except aspirin)
- Known allergies to any of the medications being used
- Allergies to chicken products
- Current use of oral steroids
- Cancer that is not cured or in remission
- Severe diabetes
- A serious infection somewhere else in the subject's body
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00198029
Start Date
October 1 2004
End Date
December 1 2009
Last Update
April 17 2017
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021