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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).
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.
Among these treatments, none to date can eliminate recurrences, which are still too frequent. Open aponeurectomy (consisting of surgical curettage of the fibrotic cords) remains for the moment the reference technique for treating Dupuytren's disease, with recurrences (between 12 and 39%), but less frequent than the needle technique (50 to 85%). Could the addition of adipose tissue in the resection areas of Dupytren's fibrosis reduce the rate of recurrence (by the inhibitory action of ADCs on myofibroblasts) in addition to reconstructing the hypodermis in the cavity left by the resection of the cords and improving the quality of the scars? The investigators insist on the fact that this is a homotopic and homologous adipose tissue graft, in closed circuit without denaturation or adjuvant products. Since, to our knowledge, no other team has used "lipofilling" as an adjuvant treatment to the open resection technique of Dupuytren's cords (aponeurectomy), the investigators first conducted a clinical feasibility and safety study on 70 patients between 2012 and 2017 (currently being published by Springer Editions). The investigators now wish to conduct a prospective comparative study between patients operated by aponeurectomy WITH (experimental group) and WITHOUT (control group) addition of autologous adipose tissue in the resection areas of Dupuytren's cords.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Institut Aquitain de la Main
Pessac, France
Santé Atlantique ELSAN
Saint-Herblain, France
Start Date
September 29, 2022
Primary Completion Date
September 29, 2025
Completion Date
September 29, 2029
Last Updated
July 10, 2025
172
ESTIMATED participants
Aponeurectomy with grafting
PROCEDURE
Aponeurectomy alone
PROCEDURE
Lead Sponsor
Elsan
NCT05440240
NCT00533273
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT03000114