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Recruiting Phase 4 NCT05440240

NCT05440240 Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture

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Clinical Trial Summary
NCT ID NCT05440240
Status Recruiting
Phase Phase 4
Sponsor Regionshospitalet Silkeborg
Condition Dupuytren Contracture
Study Type INTERVENTIONAL
Enrollment 400 participants
Start Date 2023-01-10
Primary Completion 2025-12

Trial Parameters

Condition Dupuytren Contracture
Sponsor Regionshospitalet Silkeborg
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 400
Sex ALL
Min Age 45 Years
Max Age 99 Years
Start Date 2023-01-10
Completion 2025-12
Interventions
Percutaneous needle fasciotomyCorticosteroid injectionSaline injection

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Brief Summary

Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.

Eligibility Criteria

Sufficient correction of metacarpophalangeal (MCP) joint during the PNF treatment, defined as \<20° passive extension deficit (PED), is a prerequisite for inclusion. Inclusion Criteria: * Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer * DC of either II-V finger * Well-defined/palpable cord Exclusion Criteria: * 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 co

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