RecruitingNot ApplicableNCT05067764

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

Multicenter, Randomized, Open-label Study Evaluating the Efficacy of Aponeurectomy Associated With Adipose Tissue Grafting Compared to Aponeurectomy Alone, on the 2-year Recurrence Rate of Dupuytren's Disease (REMEDY).


Sponsor

Elsan

Enrollment

172 participants

Start Date

Sep 29, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of surgery (aponeurectomy techniques) for Dupuytren's disease — a hand condition where the tissue under the skin of the palm thickens and tightens, pulling one or more fingers into a bent position. The goal is to find out which approach leads to lower recurrence rates after 2 years. You may be eligible if: - You are 18 years or older - You have Dupuytren's disease at stage II to IV on at least one finger - You have never had surgery for Dupuytren's disease - Your doctor has recommended surgery by aponeurectomy - You have enough skin thickness on the arm for the procedure You may NOT be eligible if: - You have had any previous surgery for Dupuytren's disease - Your disease affects only the thumb - You have an active autoimmune disease - You have previously been treated with collagenase injections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAponeurectomy 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.

PROCEDUREAponeurectomy 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.


Locations(2)

Institut Aquitain de la Main

Pessac, France

Santé Atlantique ELSAN

Saint-Herblain, France

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NCT05067764


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