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

Last updated: May 15, 2023
Sponsor: Regionshospitalet Silkeborg
Overall Status: Active - Recruiting

Phase

4

Condition

Musculoskeletal Diseases

Dupuytren's Disease

Connective Tissue Diseases

Treatment

Percutaneous needle fasciotomy

Saline injection

Corticosteroid injection

Clinical Study ID

NCT05440240
2022-985
2022-501021-20-00
  • Ages 45-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Sufficient correction of metacarpophalangeal (MCP) joint during the PNF treatment, definedas <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

Exclusion Criteria:

  • Legally incapacitated
  • Previous study inclusion with another finger ray
  • Isolated proximal interphalangeal (PIP) or distal interphalangeal (DIP) jointcontracture, defined as MCP joint contracture < 20° PED regardless of the deficit inthe 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

Study Design

Total Participants: 400
Treatment Group(s): 3
Primary Treatment: Percutaneous needle fasciotomy
Phase: 4
Study Start date:
January 10, 2023
Estimated Completion Date:
March 31, 2030

Connect with a study center

  • Silkeborg Regional Hospital

    Silkeborg, 8600
    Denmark

    Active - Recruiting

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