Clinical trial NCT01226121: Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
Official title: A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Dupuytren's Disease
Keywords: dupuytren
dupuytren's
Lead sponsor: Indiana Hand to Shoulder Center
Sponsor class: OTHER
Collaborators: name: Stony Brook University
First posted: 2010-10-21
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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,

Eligibility criteria: Inclusion Criteria:

* Adult subjects (\> 18 years) of either gender with an metacarpophalangeal 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

Primary outcomes:
measure: Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
timeFrame: 30 days after injection
Secondary outcomes:
measure: Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)
timeFrame: 90 days
Other outcomes:
Locations:
city: Indianaplis
country: United States
facility: Indiana Hand to Shoulder Center
state: Indiana
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Indiana Hand to Shoulder Center
name: F. Thomas D. Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stony Brook University
name: Lawrence C Hurst, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.