Actively Recruiting
Comparing Needle Aponeurotomy and Open Surgery for Treating Finger Contractures in Dupuytrens Disease
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-02
120
Participants Needed
4
Research Sites
100 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether percutaneous needle aponeurotomy is not less effective than open surgery with aponeurectomy for treating flexion contracture caused by Dupuytrens disease. This condition involves fibrosis of the palmar aponeurosis, leading to disabling joint contractures in the fingers. The study aims to determine if the minimally invasive needle procedure can reduce the need for open surgery while maintaining suitable safety and efficacy. Participants will be randomly assigned to receive either percutaneous needle aponeurotomy, which involves cutting the fibrotic cord with a needle under local anesthesia in one to three outpatient sessions, or open surgery with excision of the fibrotic tissue performed under regional anesthesia during a short hospital stay. Postoperative care including analgesics, splints, nursing, and physiotherapy is provided after surgery. Treatment completion is defined as the last needle session or stitch removal after surgery. Participants will be followed up at 1 week, 1, 3, 12, 24, and 36 months after treatment. Assessments include measuring joint contractures, range of motion, functional limitation questionnaires, patient satisfaction, complications, and recurrence. Efficacy assessments are conducted in a blinded manner, while complications are evaluated openly. The primary outcome is the degree of metacarpophalangeal joint contracture during passive extension at 3 months post-treatment.
CONDITIONS
Brief Title
Effectiveness of Percutaneous Needle Aponeurotomy
Research Team
J
Johann BEAUDREUIL, PUPH
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here