Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years old
• Ascertained Dupuytren disease: palpable fibrotic nodule or cord developed from the palmar aponeurosis, flexion contracture of a metacarpophalangeal or proximal interphalangeal joint.
• Presence of at least one flexion contracture of a metacarpophalangeal joint of the hand due to Dupuytren's disease and \> or = 20°
• Written informed consent signed by the patient
• Patient affiliated to the social security
Locations
Other Locations
France
Centre d'Imagerie Médicale Bachaumont Paris Centre
ACTIVE_NOT_RECRUITING
Paris
Hopital LARIBOISIERE - Radiologie
ACTIVE_NOT_RECRUITING
Paris
Hopital LARIBOISIERE - Rhumatologie
RECRUITING
Paris
JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur
RECRUITING
Paris
Contact Information
Primary
Johann BEAUDREUIL, PUPH
johann.beaudruil@aphp.fr
+33 1 49 95 88 28
Time Frame
Start Date:2020-11-02
Estimated Completion Date:2029-02-14
Participants
Target number of participants:120
Treatments
Experimental: 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. End of treatment will be considered as the last session of needle aponeurotomy.
Active_comparator: 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). End of surgical treatment will be considered as the removal of the stitches (two weeks after the surgical treatment).