Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

This study has been completed.
Sponsor:
Collaborator:
Stony Brook University
Information provided by (Responsible Party):
F. Thomas D. Kaplan, MD, Indiana Hand to Shoulder Center
ClinicalTrials.gov Identifier:
NCT01226121
First received: October 20, 2010
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Dupuytren's Disease
Biological: Clostridial collagenase injectable
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Indiana Hand to Shoulder Center:

Primary Outcome Measures:
  • Percentage of clinical improvement (> 50% reduction in contracture) [ Time Frame: 30 days after injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Digit range of motion [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Michigan Hand Questionaire [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: December 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Day 1 manipulation
Finger manipulation one day following collagenase injection
Biological: Clostridial collagenase injectable
Finger manipulation performed 1, 2, or 4 days following collagenase injection
Active Comparator: Day 2 manipulation
Finger manipulation two days following collagenase injection
Biological: Clostridial collagenase injectable
Finger manipulation performed 1, 2, or 4 days following collagenase injection
Active Comparator: Day 4 manipulation
Finger manipulation four days following collagenase injection
Biological: Clostridial collagenase injectable
Finger manipulation performed 1, 2, or 4 days following collagenase injection

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226121

Locations
United States, Indiana
Indiana Hand to Shoulder Center
Indianaplis, Indiana, United States, 46260
United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Indiana Hand to Shoulder Center
Stony Brook University
Investigators
Principal Investigator: F. Thomas D. Kaplan, MD Indiana Hand to Shoulder Center
Principal Investigator: Lawrence C Hurst, MD Stony Brook University
  More Information

Publications:
Responsible Party: F. Thomas D. Kaplan, MD, MD, Indiana Hand to Shoulder Center
ClinicalTrials.gov Identifier: NCT01226121     History of Changes
Other Study ID Numbers: IHtSC-Delay 101
Study First Received: October 20, 2010
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana Hand to Shoulder Center:
dupuytren
dupuytren's

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on April 17, 2014