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

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

Official Title
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Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial

Conditions
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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

Intervention / Treatment
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* Procedure: Percutaneous needle fasciotomy
* Drug: Corticosteroid injection
* Other: Saline injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Corticosteroid injection<br>Percutaneous needle fasciotomy with corticosteroid injection | Procedure: Percutaneous needle fasciotomy<br>* Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre<br>Drug: Corticosteroid injection<br>* Depo-Medrol<br>|
| Placebo Comparator: Saline injection<br>Percutaneous needle fasciotomy with saline injection | Procedure: Percutaneous needle fasciotomy<br>* Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre<br>Other: Saline injection<br>* Isotonic saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous needle fasciotomy, Corticosteroid, Randomized controlled trial