Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial
| Registry | NCT05440240 |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 400 (Estimated) |
| Sponsor | Regionshospitalet Silkeborg (Other) |
| Conditions | Dupuytren Contracture, Dupuytren's Disease, Contracture, Joint Diseases, Musculoskeletal Diseases, Fibroma, Neoplasm, Fibrous Tissue, Neoplasms, Connective Tissue, Neoplasms, Connective and Soft Tissue, Neoplasms by Histologic Type, Neoplasms, Connective Tissue Diseases |
| Interventions | Percutaneous needle fasciotomy, Corticosteroid injection, Saline injection (Procedure, drug, other) |
| Dates | start 2023-01-10, primary completion 2025-12-01 (estimated), completion 2030-03-01 (estimated), first posted 2022-06-30, last updated 2023-05-17 |
| Locations | 1 site in Denmark |
Related Papers Related Patents Related Grants Related Experts
All trials for Dupuytren Contracture All trials for Dupuytren's Disease All trials of Percutaneous needle fasciotomy All trials of Corticosteroid injection
Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Corticosteroid injection | Active comparator | Procedure: Percutaneous needle fasciotomy; Drug: Corticosteroid injection | Percutaneous needle fasciotomy with corticosteroid injection |
| Saline injection | Placebo comparator | Procedure: Percutaneous needle fasciotomy; Other: Saline injection | Percutaneous needle fasciotomy with saline injection |
Sex: All, ages: 45 Years to 99 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Silkeborg Regional Hospital | Silkeborg | Denmark | Recruiting |