Dupuytren's Disease Clinical Trial
Official title:
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05300893 -
Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture
|
N/A | |
Recruiting |
NCT04122313 -
Post-contracture Release Radiation for Dupuytren's Disease
|
||
Completed |
NCT01498640 -
Retreatment of Recurrent Dupuytren's Contractures
|
Phase 4 | |
Completed |
NCT01450397 -
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
|
Phase 4 | |
Completed |
NCT03180957 -
Repurposing Anti-TNF for Treating Dupuytren's Disease
|
Phase 2 | |
Completed |
NCT00575458 -
Splinting for Dupuytren's Contracture Release
|
N/A | |
Completed |
NCT00260429 -
Collagenase in the Treatment of Dupuytrens Disease
|
Phase 3 | |
Completed |
NCT02725528 -
Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's
|
Phase 3 | |
Completed |
NCT02193828 -
Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules
|
Phase 2 | |
Completed |
NCT00954746 -
Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859
|
N/A | |
Completed |
NCT04874870 -
Effectiveness of Splinting After Collagenase Injection
|
Phase 3 | |
Recruiting |
NCT06263699 -
Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease
|
||
Not yet recruiting |
NCT02294890 -
Knee Stiffness in Fibrosis Diathesis
|
N/A | |
Completed |
NCT04669704 -
Effectiveness of a Tele-Rehabilitation Evidence-based Tablet App for Rehabilitation in Traumatic Bone and Soft Injuries of the Hand, Wrist and Fingers.
|
N/A | |
Recruiting |
NCT05440240 -
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
|
Phase 4 | |
Recruiting |
NCT06142929 -
Micronerves in Dupuytren and the Impact of Its Dissection on Recurrence
|
||
Active, not recruiting |
NCT01446432 -
Validation of Two New Questionnaires for Dupuytren's Disease
|
N/A | |
Recruiting |
NCT06281509 -
Palmaris Longus Muscle and Dupuytren
|
N/A | |
Recruiting |
NCT06321991 -
Nodular Shrinking in Dupuytren Disease
|
Phase 2 | |
Completed |
NCT01567397 -
Registry of Dupuytren's Contracture Treatment Outcomes
|
N/A |