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Actively Recruiting

Phase 4
Age: 45Years - 99Years
All Genders
ID05440240

Randomized Trial of Needle Fasciotomy With or Without Corticosteroid Injection for Treating Dupuytrens Contracture in Finger Joints

Led by Regionshospitalet Silkeborg · Updated on 2023-05-17

400

Participants Needed

1

Research Sites

221 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of percutaneous needle fasciotomy with or without corticosteroid injection for treating Dupuytrens contracture affecting the metacarpophalangeal MCP joints. This randomized controlled trial aims to compare these two treatment options in patients aged 45 to 99 years with this joint condition. The study is led by Regionshospitalet Silkeborg and is designed as a Phase 4 clinical trial with double masking. The study includes two treatment groups one group will receive percutaneous needle fasciotomy combined with corticosteroid injection Depo-Medrol, and the other group will receive the same fasciotomy combined with a saline injection as a placebo comparator. The fasciotomy procedure follows the Lermusiaux and Debeyre technique. Participants must have sufficient correction of the MCP joint during treatment, with less than 20 degrees passive extension deficit. Participants will be monitored for outcomes including the recurrence rate of contracture after two years. Assessments will focus on the correction of joint contracture, with follow-up visits to measure the effectiveness and safety of the treatments. The trial will also evaluate secondary outcomes related to joint function and patient well-being over the study period ending in March 2030.

CONDITIONS

Brief Title

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

Research Team

L

Laura H Matthiesen, MS, PhD-student

J

Jeppe Lange, MD, PhD

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