Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | December 2010 |
| End Date: | July 2013 |
The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures
This study will evaluate the efficacy and safety of clostridial collagenase injections for
treatment of Dupuytren's contracture of the thumb and first web space. The investigators
hypothesis is that clostridial collagenase will have safety not significantly different to
that demonstrated in Phase III clinical trials, and will be effective in significantly
reducing the degree of thumb contracture.
treatment of Dupuytren's contracture of the thumb and first web space. The investigators
hypothesis is that clostridial collagenase will have safety not significantly different to
that demonstrated in Phase III clinical trials, and will be effective in significantly
reducing the degree of thumb contracture.
Inclusion Criteria:
- Adult subjects (> 18 years) of either gender with an MP and/or IP joint contracture
and a palpable cord of > 20 degrees of the thumb
- First web space contracture with a palpable cord due to Dupuytren's contracture
Exclusion Criteria:
- Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's
contracture of the same thumb.
- Any subject using anti-coagulant therapy other than low dose aspirin (up to
150mg/day).
- Any subject in the opinion of the MD investigators with chronic, severe or terminal
medical illness which would make them unsuitable for study participation.
- Any subject with known allergy to Xiaflex (Clostridial collagenase).
- Pregnant or nursing female
- Any subject who cannot conform to the study visit schedule
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