RecruitingPhase 4NCT05440240
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial
Sponsor
Regionshospitalet Silkeborg
Enrollment
400 participants
Start Date
Jan 10, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.
Eligibility
Min Age: 45 YearsMax Age: 99 Years
Inclusion Criteria4
- 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 Criteria12
- 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
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Interventions
PROCEDUREPercutaneous needle fasciotomy
Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
DRUGCorticosteroid injection
Depo-Medrol
OTHERSaline injection
Isotonic saline
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05440240
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