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

Last updated: July 7, 2025
Sponsor: Elsan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dupuytren's Disease

Treatment

Aponeurectomy alone

Aponeurectomy with grafting

Clinical Study ID

NCT05067764
REMEDY
2020-A03214-35
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Carrier of Tubiana stage II-IV Dupuytren's disease on at least one or more rays, notpreviously 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

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 thecoordinating center, not applicable for other centers)

Study Design

Total Participants: 172
Treatment Group(s): 2
Primary Treatment: Aponeurectomy alone
Phase:
Study Start date:
September 29, 2022
Estimated Completion Date:
September 29, 2029

Study Description

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.

Connect with a study center

  • Clinique du Diaconat

    Mulhouse, 68100
    France

    Site Not Available

  • Institut Aquitain de la Main

    Pessac, 33600
    France

    Active - Recruiting

  • Santé Atlantique ELSAN

    Saint-Herblain, 44800
    France

    Active - Recruiting

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