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RECRUITING
NCT03797690
NA

Effectiveness of Percutaneous Needle Aponeurotomy

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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

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