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Efficacy of Aponeurectomy on the 2-year Recurrence Rate of Dupuytren's Disease

NCT05067764 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2026-04-23

No results posted yet for this study

Summary

Dupuytren's disease is a frequent hereditary disease in Northern Europe. It is a degenerative disease affecting the palmar aponeurosis of the hand. It develops a progressive contractile fibrosis which cuts the hypodermic fatty tissue, adheres to the skin and the phalanges, gradually bending the affected rays, resulting in significant functional impotence.

Various medical and surgical treatments are available.

Conditions

  • Dupuytren's Disease

Interventions

PROCEDURE

Aponeurectomy with grafting

The lipofilling is performed, once the incisions are closed and is performed with the Puregraft® system. The fat graft is taken from the posterior, medial and anterior sides of the arm, by skin puncture. Approximately 10 cc are harvested, allowing a reinjection of about 2 cc per digital radius treated. After conditioning, the fat graft is redistributed to the curettage areas through the skin incisions.

PROCEDURE

Aponeurectomy alone

The patient is installed in dorsal decubitus position and the arm to be treated is anesthetized by axillary block. The procedure is performed in the operating room, respecting all the rules of asepsis and safety in force. A tourniquet is placed on the arm to be treated and inflated to 250mmHg. Broken incisions are then made opposite the cords to be excised, which are located by palpation. Once the noble elements have been identified, the excision of the cords and fibrous nodules can be done as completely as possible. Sometimes an arthrolysis procedure is necessary in order to restore extension to a joint that has been fixed in a flexion position for several years. Skin closure is most often possible by direct suture or by means of local fatty skin flaps. In some cases, the surgeon may use total skin grafts, or directed healing in certain areas where direct skin suture is not possible.

Sponsors & Collaborators

  • Elsan

    lead OTHER

Principal Investigators

  • Elias SAWAYA, MD · Institut Aquitain de la Main

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-29
Primary Completion
2027-03-29
Completion
2030-03-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05067764 on ClinicalTrials.gov