RecruitingPhase 4NCT05440240

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

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


Sponsor

Regionshospitalet Silkeborg

Enrollment

400 participants

Start Date

Jan 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 45 YearsMax Age: 99 Years

Inclusion Criteria4

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

Exclusion Criteria12

  • 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

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Interventions

PROCEDUREPercutaneous needle fasciotomy

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

DRUGCorticosteroid injection

Depo-Medrol

OTHERSaline injection

Isotonic saline


Locations(1)

Silkeborg Regional Hospital

Silkeborg, Denmark

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NCT05440240


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