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).
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years
• Carrier of Tubiana stage II-IV Dupuytren's disease on at least one or more rays, not previously operated
• Indication of a surgery by aponeurectomy
• Skin pinch of the posterior aspect of the arm of more than 1cm
• Affiliation to a social security system
• Patient informed of the study and having given informed consent
Locations
Other Locations
France
Institut Aquitain de la Main
RECRUITING
Pessac
Santé Atlantique ELSAN
RECRUITING
Saint-herblain
Contact Information
Primary
Elias SAWAYA, MD
esawaya.md@gmail.com
(0)663420278
Time Frame
Start Date: 2022-09-29
Estimated Completion Date: 2029-09-29
Participants
Target number of participants: 172
Treatments
Experimental: Aponeurectomy with grafting
The experimental group evaluates the aponeurectomy associated with adipose tissue grafting.
Active_comparator: Aponeurectomy alone
The control group evaluates the aponeurectomy alone.
Related Therapeutic Areas
Sponsors
Leads: Elsan