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

Phase 4

Recruiting

• Conditions: Dupuytren Contracture; Joint Diseases; Fibroma; Neoplasms, Connective Tissue; Neoplasms by Histologic Type; Neoplasms; Dupuytren's Disease; Contracture; Musculoskeletal Diseases; Neoplasm, Fibrous Tissue
• Interventions: Procedure: Percutaneous needle fasciotomy; Drug: Corticosteroid injection; Other: Saline injection

• Registration Number: NCT05440240
• Lead Sponsor: Regionshospitalet Silkeborg

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Study Start: 2023-01-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-17
• Primary Completion: 2025-12
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid injection	Corticosteroid injection	Percutaneous needle fasciotomy with corticosteroid injection
Saline injection	Percutaneous needle fasciotomy	Percutaneous needle fasciotomy with saline injection
Saline injection	Saline injection	Percutaneous needle fasciotomy with saline injection
Corticosteroid injection	Percutaneous needle fasciotomy	Percutaneous needle fasciotomy with corticosteroid injection

Primary Outcome Measures

Name	Time	Method
Recurrence rate	2 years	Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline

Trial Locations

Locations (1)

Silkeborg Regional Hospital; 🇩🇰 Silkeborg, Denmark