Clinical trial · Interventional
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).
NCT05067764CI-TRIAL-00109243REMEDYrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dupuytren's Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aponeurectomy alone | Procedure | — | UNRESOLVED |
| Aponeurectomy with grafting | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aponeurectomy with grafting
- description
- The experimental group evaluates the aponeurectomy associated with adipose tissue grafting.
- interventionNames
- Procedure: Aponeurectomy with grafting
- type
- ACTIVE_COMPARATOR
- label
- Aponeurectomy alone
- description
- The control group evaluates the aponeurectomy alone.
- interventionNames
- Procedure: Aponeurectomy alone
Primary outcomes (1)
- measure
- 2-year recurrence rate of Dupuytren's disease
- timeFrame
- 2 Years after intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Previous surgery of any kind for Dupuytren's disease * Involvement on the thumb only * Need for a total skin graft or a pedicle flap on all the rays to be treated * Active autoimmune disease * Previous treatment with collagenase * Pregnant and breastfeeding women * Patient under legal protection * Contraindications to MRI (criteria applicable only for patients from the coordinating center, not applicable for other centers)
References
Publications (12)
- BACKGROUNDSelles RW, Zhou C, Kan HJ, Wouters RM, van Nieuwenhoven CA, Hovius SER. Percutaneous Aponeurotomy and Lipofilling versus Limited Fasciectomy for Dupuytren's Contracture: 5-Year Results from a Randomized Clinical Trial. Plast Reconstr Surg. 2018 Dec;142(6):1523-1531. doi: 10.1097/PRS.0000000000004982. PMID 30489526
- BACKGROUNDHenry M. Dupuytren's disease: current state of the art. Hand (N Y). 2014 Mar;9(1):1-8. doi: 10.1007/s11552-013-9563-0. PMID 24570630
- BACKGROUNDEngstrand C, Krevers B, Nylander G, Kvist J. Hand function and quality of life before and after fasciectomy for Dupuytren contracture. J Hand Surg Am. 2014 Jul;39(7):1333-1343.e2. doi: 10.1016/j.jhsa.2014.04.029. PMID 24969497
- BACKGROUNDColeman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7. PMID 16936550
- BACKGROUNDZuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859. PMID 11304456
- BACKGROUNDMojallal A, Lequeux C, Shipkov C, Breton P, Foyatier JL, Braye F, Damour O. Improvement of skin quality after fat grafting: clinical observation and an animal study. Plast Reconstr Surg. 2009 Sep;124(3):765-774. doi: 10.1097/PRS.0b013e3181b17b8f. PMID 19730294
- BACKGROUNDVerhoekx JSN, Mudera V, Walbeehm ET, Hovius SER. Adipose-derived stem cells inhibit the contractile myofibroblast in Dupuytren's disease. Plast Reconstr Surg. 2013 Nov;132(5):1139-1148. doi: 10.1097/PRS.0b013e3182a3bf2b. PMID 23924646
- Foucher G, Medina J, Navarro R. Percutaneous needle aponeurotomy: complications and results. J Hand Surg Br. 2003 Oct;28(5):427-31. doi: 10.1016/s0266-7681(03)00013-5.