Elsan Group, Hôpital Privé St Martin, Institut Aquitain de La Main, Pessac, France.
Elsan Group, Cellule Recherche Clinique Nouvelle Aquitaine, Bordeaux, France.
Trials. 2024 Sep 2;25(1):577. doi: 10.1186/s13063-024-08410-4.
Dupuytren's contracture is a hereditary disorder which causes progressive fibrosis of the palmar aponeurosis of the hand, resulting in digital flexion contractures of the affected rays. Limited fasciectomy is a standard surgical treatment for Dupuytren's, and the one with the lowest recurrence rate; however, the recurrence is still relatively high (2-39%). Adipose-derived stem cells have been shown to inhibit Dupuytren's myofibroblasts proliferation and contractility in vitro, as well as to improve scar quality and skin regeneration in different types of surgeries. Autologous adipose tissue grafting has already been investigated as an adjuvant treatment to percutaneous needle fasciotomy for Dupuytren's contracture with good results, but it was only recently associated with limited fasciectomy. The purpose of REMEDY trial is to investigate if limited fasciectomy with autologous adipose tissue grafting would decrease recurrence compared to limited fasciectomy alone.
The REMEDY trial is a multi-centre open-label randomised controlled trial (RCT) with 1:1 allocation ratio. Participants (n = 150) will be randomised into two groups, limited fasciectomy with autologous adipose tissue grafting versus limited fasciectomy alone. The primary outcome is the recurrence of Dupuytren's contracture on any of the treated rays at 2 years postoperatively. The secondary outcomes are recurrence at 3 and 5 years, scar quality, complications, occurrence of algodystrophy (complex regional pain syndrome), patient-reported hand function, and hypodermal adipose tissue loss at 1 year postoperatively in a small subset of patients.
The REMEDY trial is one of the first studies investigating limited fasciectomy associated with autologous adipose tissue grafting for Dupuytren's contracture, and, to our knowledge, the first one investigating long-term outcomes of this treatment. It will provide insight into possible benefits of combining adipose tissue grafting with limited fasciectomy, such as lower recurrence rate and improvement of scar quality.
ClinicalTrials.gov NCT05067764, June 13, 2022.
杜普伊特伦挛缩症是一种遗传性疾病，导致手部掌腱膜进行性纤维化，导致受累射线的手指屈曲挛缩。局限性筋膜切开术是治疗杜普伊特伦挛缩症的标准手术方法，其复发率最低；然而，复发率仍然相对较高（2-39%）。脂肪源性干细胞已被证明可在体外抑制杜普伊特伦氏肌成纤维细胞的增殖和收缩性，并改善不同类型手术中的疤痕质量和皮肤再生。自体脂肪组织移植已被研究作为经皮针刀松解术治疗杜普伊特伦挛缩症的辅助治疗方法，效果良好，但最近才与局限性筋膜切开术相关联。REMEDY 试验的目的是研究与单独进行局限性筋膜切开术相比，局限性筋膜切开术联合自体脂肪组织移植是否会降低复发率。
REMEDY 试验是一项多中心开放性标签随机对照试验（RCT），采用 1:1 分配比。参与者（n=150）将被随机分为两组，一组接受局限性筋膜切开术联合自体脂肪组织移植，另一组仅接受局限性筋膜切开术。主要结局是术后 2 年任何治疗射线的杜普伊特伦挛缩复发。次要结局包括 3 年和 5 年的复发率、疤痕质量、并发症、algodystrophy（复杂性区域疼痛综合征）的发生、患者报告的手部功能以及术后 1 年少量患者的皮下脂肪组织丢失。
REMEDY 试验是第一项研究局限性筋膜切开术联合自体脂肪组织移植治疗杜普伊特伦挛缩症的研究之一，据我们所知，也是第一项研究该治疗方法长期结局的研究。它将为联合脂肪组织移植与局限性筋膜切开术带来的可能益处提供见解，例如降低复发率和改善疤痕质量。
ClinicalTrials.gov NCT05067764，2022 年 6 月 13 日。
