Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/3/2014 |
Start Date: | December 2010 |
End Date: | December 2012 |
A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
The purpose of this study is to determine if of manipulation of digits following collagenase
injection for treatment of Dupuytren's contracture is effected by the amount of time between
injection and manipulation.
injection for treatment of Dupuytren's contracture is effected by the amount of time between
injection and manipulation.
Patients with Metacarpophalangeal joint contractures caused by Dupuytren's disease will be
evaluated as to the timing of the finger manipulation procedure that is performed following
collagenase injection. Three groups will be evaluated: group 1 will have the manipulation
procedure on the day following collagenase injection, group 2 will have the manipulation
procedure on the second day following collagenase injection,and group 3 will have the
manipulation procedure on the fourth day following collagenase injection,
evaluated as to the timing of the finger manipulation procedure that is performed following
collagenase injection. Three groups will be evaluated: group 1 will have the manipulation
procedure on the day following collagenase injection, group 2 will have the manipulation
procedure on the second day following collagenase injection,and group 3 will have the
manipulation procedure on the fourth day following collagenase injection,
Inclusion Criteria:
- Adult subjects (> 18 years) of either gender with an MP joint contracture and a
palpable cord of > 20 degrees of a digit (excluding the thumb) due to Dupuytren's
contracture
Exclusion Criteria:
- Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex
treatment for Dupuytren's contracture.
- 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).
- Any subject who cannot conform to the study visit schedule
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