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NCT05440240 Clinical Trial

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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05440240
Other study ID # 2022-985
Secondary ID 2022-501021-20-0
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 10, 2023
Est. completion date March 2030

Study information
Verified date May 2023
Source Regionshospitalet Silkeborg
Contact Laura H Matthiesen, MS, PhD-student
Phone 004561281917
Email lather@rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date March 2030
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 45 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Denmark Silkeborg Regional Hospital Silkeborg

Sponsors (1)
Lead Sponsor Collaborator
Regionshospitalet Silkeborg

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence rate Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline 2 years
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