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Effectiveness of Percutaneous Needle Aponeurotomy
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
The main objective is to investigate if percutaneous needle aponeurotomy is non-inferior to open surgery using aponeurectomy in treatment of flexion contracture due to Dupuytren's disease. Our hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren's disease and that it is consequently able to drastically reduce the need of open surgery in this indication.
Official title: Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2020-11-02
Completion Date
2029-02-14
Last Updated
2025-04-02
Healthy Volunteers
No
Conditions
Interventions
Percutaneous needle aponeurotomy
It consists in cutting the fibrotic cord due to the disease and responsible for the flexion contracture, with a needle under local anesthesia. The procedure can be repeated as required during the same session. One to three sessions with at least one-week interval are usually sufficient and will be allowed. It will be performed in outpatient setting by a senior physician experienced in the procedure
Open surgery with limited aponeurectomy
It consists in excision of the fibrotic aponeurosis.It will be performed by hand surgeons under loco-regional anaesthesia during a short hospitalization (1 day stay). Post-operative cares are necessary (analgesics, splint, nursing, physiotherapy)
Locations (4)
Centre d'Imagerie Médicale Bachaumont Paris Centre
Paris, France
Hopital LARIBOISIERE - Radiologie
Paris, France
Hopital LARIBOISIERE - Rhumatologie
Paris, France
JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur
Paris, France