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

• Sponsor: Regionshospitalet Silkeborg (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05440240
• Collaborator: (none)
• Enrollment: 400
• Arms: 2
• Anticipated Duration (Months): 87

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dupuytren Contracture; Dupuytren's Disease; Contracture; Joint Diseases; Musculoskeletal Diseases; Fibroma; Neoplasm, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases	Procedure: Percutaneous needle fasciotomy; Drug: Corticosteroid injection; Other: Saline injection	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Dec 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Corticosteroid injection Percutaneous needle fasciotomy with corticosteroid injection	Procedure: Percutaneous needle fasciotomy; Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre; Drug: Corticosteroid injection; Depo-Medrol
Placebo Comparator: Saline injection Percutaneous needle fasciotomy with saline injection	Procedure: Percutaneous needle fasciotomy; Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre; Other: Saline injection; Isotonic saline

Outcome Measures

Primary Outcome Measures

1. Recurrence rate [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Regionshospitalet Silkeborg

Investigators

• Study Director: Jeppe Lange, MD, PhD, Horsens Regional Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laura Houstrup Matthiesen, PhD Student, Regionshospitalet Silkeborg
• ClinicalTrials.gov Identifier: NCT05440240
• Other Study ID Numbers: 2022-985; 2022-501021-20-00
• First Posted: Jun 30, 2022
• Last Update Posted: Jul 6, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Laura Houstrup Matthiesen, PhD Student, Regionshospitalet Silkeborg: Percutaneous needle fasciotomy; Corticosteroid; Randomized controlled trial
• Additional relevant MeSH terms: Neoplasms; Neoplasms by Histologic Type; Dupuytren Contracture; Fibroma; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Joint Diseases; Musculoskeletal Diseases; Contracture; Connective Tissue Diseases

Study Results

No Results Posted as of Jul 6, 2022