Multicenter, Randomized, Open-label Study Evaluating the Efficacy of Aponeurectomy with Adipose Tissue Grafting Compared to Aponeurectomy Alone on 2-year Recurrence Rate of Dupuytren's Disease

What this Trial Is About

Dupuytren's disease is a common hereditary condition in Northern Europe that causes progressive fibrosis in the hand's palmar aponeurosis. This fibrosis leads to bending of the fingers, resulting in significant functional impairment. Various medical and surgical treatments exist, but none fully prevent recurrence of the disease. This trial investigates whether adding autologous adipose tissue grafting to open aponeurectomy can reduce the 2-year recurrence rate of Dupuytren's disease compared to aponeurectomy alone. The study compares two groups: one receiving standard open aponeurectomy alone and the other receiving aponeurectomy combined with adipose tissue grafting. The grafting involves harvesting fat from the arm and injecting it into areas where fibrotic cords were removed, aiming to reconstruct tissue and potentially inhibit fibrosis. Both procedures are performed under anesthesia and follow standard surgical safety practices. Participants will be monitored over several years to assess recurrence rates at 2, 3, and 5 years after surgery. Other evaluations include scar appearance, complication rates shortly after surgery, occurrence of algodystrophy, and quality of life impacts at multiple time points. Researchers will conduct follow-up visits to collect data on these outcomes and overall safety, with participant involvement lasting up to five years post intervention.

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