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NCT Number: NCT05440240

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

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

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Key information

Conditions

Dupuytren Contracture Connective Tissue Diseases Contracture Dupuytren's Disease Fibroma Joint Diseases Muscular Diseases Musculoskeletal Diseases Neoplasm, Fibrous Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

45 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous needle fasciotomy

Procedure

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Corticosteroid injection

Drug

Depo-Medrol

Saline injection

Other

Isotonic saline

Primary outcomes

  1. Recurrence rate

    Time frame: 2 years

    Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Jeppe Lange, MD, PhD

CONTACT

[email protected]

Laura H Matthiesen, MS, PhD-student

CONTACT

[email protected]

004561281917

Sponsors and collaborators

Lead sponsor

Regionshospitalet Silkeborg

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2030
First posted
Jun 30, 2022
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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