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Clinical Trials in Denmark / NCT05440240
Recruiting Phase 4

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

NCT05440240 · tracked via the Priya Life Science Denmark tracker
Sponsor
Regionshospitalet Silkeborg
Phase
Phase 4
Started
2023-01-10
Last updated
2023-05-17

Condition(s) studied

Dupuytren ContractureDupuytren's DiseaseContractureJoint DiseasesMusculoskeletal DiseasesFibromaNeoplasm, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue Diseases

Investigational drug(s) / intervention(s)

Percutaneous needle fasciotomyCorticosteroid injectionSaline injection

Percutaneous needle fasciotomy: Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Corticosteroid injection: Depo-Medrol

Saline injection: Isotonic saline

Study summary

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

Eligibility

Sex
ALL
Min age
45 Years
Max age
99 Years
Healthy volunteers
No
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 communicate, cooperate or participate in follow-up

Primary outcome measure(s)

  • Recurrence rate — 2 years
    Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline

Trial sites (1)

FacilityCityRegionStatus
Silkeborg Regional Hospital Silkeborg Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05440240 on ClinicalTrials.gov ↗ ← All trials in Denmark