N/A
N=32
An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
Carpometacarpal Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00198029 ↗Enrolled (actual)
32
Serious AEs
9.4%
Results posted
Jun 2013
Primary outcome: Primary: The Disabilities of the Arm, Shoulder and Hand Outcome Measure — 12.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Synvisc (hylan G-F20) (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Disabilities of the Arm, Shoulder and Hand Outcome Measure |
12.6 | — |
| SECONDARY Visual Analog Scale for Pain |
15.2 | — |
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 ultrasound is at visualizing medication in the thumb joint. We are no longer recruiting for this part of the open label trial.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00198029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.