Clinical trial NCT05067764: 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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dupuytren's Disease
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, prospective, therapeutic, comparative, randomized controlled open-label, superiority, multicenter, national study.
Primary purpose: PREVENTION

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.

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.

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)

Primary outcomes:
measure: 2-year recurrence rate of Dupuytren's disease
timeFrame: 2 Years after intervention
Secondary outcomes:
measure: 3-year recurrence rate in both groups
timeFrame: 3 Years after intervention
measure: 5-year recurrence rate in both groups
timeFrame: 5 Years after intervention
measure: Comparison of the appearance of scars in both groups
timeFrame: 1 Year after intervention
measure: Comparison of the appearance of scars in both groups
timeFrame: 2 Years after intervention
measure: Comparison of the complication rates in both groups
timeFrame: 1 Week after intervention
measure: Comparison of the complication rates in both groups
timeFrame: 6 Weeks after intervention
measure: Comparison of the rate of occurrence of algodystrophy, regardless of cause
timeFrame: 1 Year after intervention
measure: Comparison of the rate of occurrence of algodystrophy, regardless of cause
timeFrame: 2 Years after intervention
measure: Comparison of the rate of occurrence of algodystrophy, regardless of cause
timeFrame: 3 Years after intervention
measure: Comparison of the rate of occurrence of algodystrophy, regardless of cause
timeFrame: 5 Years after intervention
measure: Evaluation of hypodermic fat volume loss
timeFrame: 1 Year after intervention
measure: Comparison of the effect on quality of life in both groups
timeFrame: 6 Weeks after intervention
measure: Comparison of the effect on quality of life in both groups
timeFrame: 1 Year after intervention
measure: Comparison of the effect on quality of life in both groups
timeFrame: 2 Years after intervention
measure: Comparison of the effect on quality of life in both groups
timeFrame: 5 Years after intervention
measure: Evaluation of the safety of aponectomy surgery associated or not with adipose tissue grafting
timeFrame: 6 Weeks after intervention
measure: Evaluation of the primary endpoint on the second hand operated on.
timeFrame: Within five years after intervention
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: Clinique du Diaconat
city: Pessac
country: France
facility: Institut Aquitain de la Main
Study officials:
affiliation: Institut Aquitain de la Main
name: Elias SAWAYA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.