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

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).

Overview

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.

Detailed 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.

Interventions

• Procedure Aponeurectomy with grafting
  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.
• Procedure Aponeurectomy alone
  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 c

Primary outcome measures

• 2-year recurrence rate of Dupuytren's disease [Time frame: 2 Years after intervention]

Secondary outcome measures (12)

• 3-year recurrence rate in both groups [Time frame: 3 Years after intervention]
• 5-year recurrence rate in both groups [Time frame: 5 Years after intervention]
• Comparison of the appearance of scars in both groups [Time frame: 1 Year after intervention]
• Comparison of the appearance of scars in both groups [Time frame: 2 Years after intervention]
• Comparison of the complication rates in both groups [Time frame: 1 Week after intervention]
• Comparison of the complication rates in both groups [Time frame: 6 Weeks after intervention]
• Comparison of the rate of occurrence of algodystrophy, regardless of cause [Time frame: 1 Year after intervention]
• Comparison of the rate of occurrence of algodystrophy, regardless of cause [Time frame: 2 Years after intervention]
• Comparison of the rate of occurrence of algodystrophy, regardless of cause [Time frame: 3 Years after intervention]
• Comparison of the rate of occurrence of algodystrophy, regardless of cause [Time frame: 5 Years after intervention]
• Comparison of the effect on quality of life in both groups [Time frame: 6 Weeks after intervention]
• Comparison of the effect on quality of life in both groups [Time frame: 1 Year after intervention]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

France · 2 centers

• Institut Aquitain de la Main — Pessac
• Santé Atlantique ELSAN — Saint-Herblain

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT05067764 · REMEDY · 2020-A03214-35

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗