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

Elsan

Status: Enrolling

Conditions: Dupuytren's Disease

Treatments: Procedure: Aponeurectomy alone; Procedure: Aponeurectomy with grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT05067764

REMEDY

2020-A03214-35 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

172 participants in 2 patient groups

Aponeurectomy with grafting

Experimental group

Description:

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

Treatment:

Procedure: Aponeurectomy with grafting

Aponeurectomy alone

Active Comparator group

Description:

The control group evaluates the aponeurectomy alone.

Treatment:

Procedure: Aponeurectomy alone