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Recruiting NCT05440240

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

Phase IV Interventional Dupuytren Contracture Dupuytren's Disease Contracture Joint Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Percutaneous needle fasciotomy, Corticosteroid injection, Saline injection.
Who it may be relevant to
Registry conditions: Dupuytren Contracture, Dupuytren's Disease, Contracture, Joint Diseases. Basic parameters: 45 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Procedure Percutaneous needle fasciotomy
    Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
  • Drug Corticosteroid injection
    Depo-Medrol
  • Other Saline injection
    Isotonic saline

Primary outcome measures

  • Recurrence rate [Time frame: 2 years]

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 communicate, cooperate or participate in follow-up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Silkeborg Regional Hospital — Silkeborg

Publications

  • Matthiesen LH, Skov ST, Lange J. Adjuvant steroid to percutaneous needle fasciotomy for Dupuytren's contracture. An RCT study protocol. Dan Med J. 2024 Nov 12;71(12):A05240324. doi: 10.61409/A05240324. PMID 39749555

Identifiers

NCT: NCT05440240 · 2022-985 · 2022-501021-20-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗