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).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 172
- 试验地点
- 4
- 主要终点
- 2-year recurrence rate of Dupuytren's disease
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
2-year recurrence rate of Dupuytren's disease
时间窗: 2 Years after intervention
Recurrence being defined as follows: appearance, at 2 years post-op compared to 6 weeks post-op, of a contracture of more than 20 degrees, with palpable cord, on any treated joint.
次要结局
- 3-year recurrence rate in both groups(3 Years after intervention)
- 5-year recurrence rate in both groups(5 Years after intervention)
- Comparison of the appearance of scars in both groups(2 Years after intervention)
- Comparison of the complication rates in both groups(6 Weeks after intervention)
- Comparison of the rate of occurrence of algodystrophy, regardless of cause(5 Years after intervention)
- Comparison of the effect on quality of life in both groups(5 Years after intervention)
- Evaluation of the primary endpoint on the second hand operated on.(Within five years after intervention)
- Comparison of the complication rates in both groups(6 Weeks after intervention)
- Comparison of the rate of occurrence of algodystrophy, regardless of cause(5 Years after intervention)
- Comparison of the effect on quality of life in both groups(5 Years after intervention)
- Evaluation of the primary endpoint on the second hand operated on.(Within five years after intervention)
- 3-year recurrence rate in both groups(3 Years after intervention)
- Comparison of the appearance of scars in both groups(2 Years after intervention)