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

NCT05067764 | Recruiting

• 2 other identifiers: REMEDY2020-A03214-35
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dupuytren's Disease

Outcome Measures

Primary Outcomes (1)

• 2-year recurrence rate of Dupuytren's disease

  Recurrence being defined as follows: appearance, at 2 years post-op compared to 6 weeks post-op, of a contracture of more than 20 degrees, with palpable cord, on any treated joint.

  2 Years after intervention

Secondary Outcomes (15)

• 3-year recurrence rate in both groups

  3 Years after intervention

• 5-year recurrence rate in both groups

  5 Years after intervention

• Comparison of the appearance of scars in both groups

  1 Year after intervention

• Comparison of the appearance of scars in both groups

  2 Years after intervention

• Comparison of the complication rates in both groups

  1 Week after intervention

Study Arms (2)

Aponeurectomy with grafting

EXPERIMENTAL

The experimental group evaluates the aponeurectomy associated with adipose tissue grafting.

Procedure: Aponeurectomy with grafting

Aponeurectomy alone

ACTIVE COMPARATOR

The control group evaluates the aponeurectomy alone.

Procedure: Aponeurectomy alone

Interventions

Aponeurectomy with grafting PROCEDURE

The lipofilling is performed, once the incisions are closed and is performed with the Puregraft® system. The fat graft is taken from the posterior, medial and anterior sides of the arm, by skin puncture. Approximately 10 cc are harvested, allowing a reinjection of about 2 cc per digital radius treated. After conditioning, the fat graft is redistributed to the curettage areas through the skin incisions.

Aponeurectomy with grafting

Aponeurectomy alone PROCEDURE

The patient is installed in dorsal decubitus position and the arm to be treated is anesthetized by axillary block. The procedure is performed in the operating room, respecting all the rules of asepsis and safety in force. A tourniquet is placed on the arm to be treated and inflated to 250mmHg. Broken incisions are then made opposite the cords to be excised, which are located by palpation. Once the noble elements have been identified, the excision of the cords and fibrous nodules can be done as completely as possible. Sometimes an arthrolysis procedure is necessary in order to restore extension to a joint that has been fixed in a flexion position for several years. Skin closure is most often possible by direct suture or by means of local fatty skin flaps. In some cases, the surgeon may use total skin grafts, or directed healing in certain areas where direct skin suture is not possible.

Aponeurectomy alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Elsan: lead

Study Sites (2)

Institut Aquitain de la Main

Pessac, 33600, France

RECRUITING

Santé Atlantique ELSAN

Saint-Herblain, 44800, France

RECRUITING

Related Publications (12)

• Selles 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 BACKGROUND

• Henry 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 BACKGROUND

• Engstrand 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 BACKGROUND

• Coleman 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 BACKGROUND

• Zuk 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 BACKGROUND

• Mojallal 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 BACKGROUND

• Verhoekx 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 BACKGROUND

• 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.

  PMID: 12954251 BACKGROUND

• Kan HJ, Verrijp FW, Hovius SER, van Nieuwenhoven CA; Dupuytren Delphi Group; Selles RW. Recurrence of Dupuytren's contracture: A consensus-based definition. PLoS One. 2017 May 15;12(5):e0164849. doi: 10.1371/journal.pone.0164849. eCollection 2017.

  PMID: 28505187 BACKGROUND

• Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.

  PMID: 15866967 BACKGROUND

• Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):920-6. doi: 10.1016/j.jse.2008.12.015. Epub 2009 Mar 17.

  PMID: 19297202 BACKGROUND

• Sawaya ET, Sommier B, Alet JM, Piechaud PT; REMEDY Study Group; ReSurg; Lecoq FA. Limited fasciectomy with versus without autologous adipose tissue grafting for treatment of Dupuytren's contracture (REMEDY): study protocol for a multicentre randomised controlled trial. Trials. 2024 Sep 2;25(1):577. doi: 10.1186/s13063-024-08410-4.

  PMID: 39223657 DERIVED

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Elias SAWAYA, MD

  Institut Aquitain de la Main

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elias SAWAYA, MD

CONTACT

(0)663420278; esawaya.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, prospective, therapeutic, comparative, randomized controlled open-label, superiority, multicenter, national study.

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 5, 2021
• Study Start: September 29, 2022
• Primary Completion (Estimated): March 29, 2027
• Study Completion (Estimated): March 29, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)