Treatment options for Dupuytren's contracture
Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial
This study is testing whether adding a corticosteroid injection to a needle treatment helps people with Dupuytren's contracture move their fingers better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 45 Years to 99 Years |
| Sex | All |
| Sponsor | Regionshospitalet Silkeborg Academic / other |
| Locations | 1 site (Silkeborg) |
| Trial ID | NCT05440240 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of percutaneous needle fasciotomy with and without corticosteroid injection for treating Dupuytren's contracture affecting the metacarpophalangeal joints. It is a multicenter, randomized controlled trial designed to assess the outcomes of these interventions. Participants will be evaluated based on their passive extension deficit to determine the success of the treatment. The study aims to provide insights into the best approach for managing this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with Dupuytren contracture exhibiting a passive extension deficit of 20° or more in the metacarpophalangeal joint.
Not a fit: Patients with isolated proximal interphalangeal or distal interphalangeal joint contractures, or those with previous hand surgery on the affected finger, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from Dupuytren's contracture.
How similar studies have performed: Other studies have shown promise in using percutaneous needle fasciotomy for Dupuytren's contracture, indicating that this approach is not entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Silkeborg
- Silkeborg Regional Hospital — Silkeborg, Denmark (Recruiting)
Study contacts
- Study coordinator: Laura H Matthiesen, MS, PhD-student
- Email: lather@rm.dk
- Phone: 004561281917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.