A prospective randomised pilot study comparing patient outcomes and cost-effectiveness of injectable collagenase fasciotomy with percutaneous needle fasciotomy for the treatment of Dupuytren’s disease of the hand
Phase 3
Withdrawn
- Conditions
- Dupuytrens diseaseOther - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)Human Genetics and Inherited Disorders - Other human genetics and inherited disorders
- Registration Number
- ACTRN12618001240235
- Lead Sponsor
- aunceston General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Dupuytren’s disease with contracture (20-100 degrees Metacarpo-phalyngeal (MCP) joint or 20-80 at the proximal interphalyngeal (PIP) joint.)
Consulting clinician deems it appropriate management for the patient to have one or other of the fasciotomy procedures
No previous treatment within 90 days
Able to provide informed consent; age 18 years and older
Exclusion Criteria
Bleeding disorder, blood thinning treatment (except aspirin 150mg/day)
Allergy to collagenase ; pregnancy, breast feeding; neuromuscular disorders
Administration of tetracyclines, antracyclines or anthraquinones in the past 14 days (these meds inhibit matrix metalloproteinase-mediate collagen degradation at suprapharmacological concentrations in vitro).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in angle of flexion in the primary randomised joint. Measured by a blinded hand therapist using a goniometer.[One month];Proportion of successful procedures as measured by the degree of contracture <5 degrees. This will be measured using a goniometer.[One month]
- Secondary Outcome Measures
Name Time Method The Unite Rhumatologique des Affections de la Main (URAM) scale [4 weeks, 3 months and 2 years];Disabilities of the arm, shoulder and hand (DASH) outcome questionnaire [4 weeks, 3 months and 2 years];Requires further surgical management of the treated cords (Yes/No)[2 years post intervention]