Status:
RECRUITING
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
Lead Sponsor:
Regionshospitalet Silkeborg
Conditions:
Dupuytren Contracture
Dupuytren's Disease
Eligibility:
All Genders
45-99 years
Phase:
PHASE4
Brief Summary
Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.
Eligibility Criteria
Inclusion
- Sufficient correction of metacarpophalangeal (MCP) joint during the PNF treatment, defined as \<20° passive extension deficit (PED), is a prerequisite for inclusion.
- Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer
- DC of either II-V finger
- Well-defined/palpable cord
Exclusion
- Legally incapacitated
- Previous study inclusion with another finger ray
- Isolated proximal interphalangeal (PIP) or distal interphalangeal (DIP) joint contracture, defined as MCP joint contracture \< 20° PED regardless of the deficit in the PIP or DIP joint
- Previous hand surgery of the affected finger for any reason
- Known allergy to the study medication
- Anticoagulant therapy (Acetylsalicylic acid is NOT an exclusion criterion)
- Pregnant or lactation
- Insulin dependent diabetes mellitus
- Ongoing systemic infection or local infection at the site of the procedure
- Rheumatoid arthritis
- Amyloidosis or mucopolysaccharidosis
- Unable to communicate, cooperate or participate in follow-up
Key Trial Info
Start Date :
January 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05440240
Start Date
January 10 2023
End Date
March 1 2030
Last Update
May 17 2023
Active Locations (1)
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1
Silkeborg Regional Hospital
Silkeborg, Denmark, 8600