Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Metacarpophalangeal joint contracture during passive extension
研究概览
简要总结
The main objective is to investigate if percutaneous needle aponeurotomy is non-inferior to open surgery using aponeurectomy in treatment of flexion contracture due to Dupuytren's disease.
Our hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren's disease and that it is consequently able to drastically reduce the need of open surgery in this indication.
详细描述
Scientific justification:
Dupuytren's disease is a world-wide musculoskeletal disorder. It consists in fibrosis of the palmar aponeurosis that can induce disabling flexion contracture of the metacarpophalageal or proximal interphalangeal joints. Treatment modalities of flexion contracture include open surgery, percutaneous needle aponeurotomy and collagenase. Collagenase is not available in France. Aponeurectomy, that is also called fasciectomy, is the main open surgical technique, and open surgery is the most frequently used treatment in Dupuytren's disease. Percutaneous needle aponeurotomy is recommended as a nonsurgical treatment for Dupuytren's disease. It is a minimally invasive procedure. Its most largely accepted indication is Dupuytren's disease with metacarpophalageal joint involvement. However, percutaneous needle aponeurotomy has been successful for metacarpophalageal or proximal interphalangeal joint involvement, in nonadvanced and in advanced Dupuytren's disease. A model analysis recently demonstrated that replacing open surgery with percutaneous needle aponeurotomy could save more than 50% of the total hospitalization costs for the disease.
Percutaneous needle aponeurotomy therefore appears as a unique minimally invasive approach for Dupuytren's disease. It could become a valuable alternative to open surgery. The hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren's disease and that it is consequently able to drastically reduce the need of open surgery in this indication.
Practical procedure:
Patients addressed to the consultation of the hand surgery centers for Dupuytren's disease will be prospectively selected, included, randomized, treated using percutaneous needle aponeurotomy or open surgery within six weeks after randomization, and followed at 1 week, 1, 3,12, 24 and 36 months after treatment. Assessment of efficacy will be blinded. Assessment of complications will be done by an unblinded assessor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The primary outcome (main metacarpophalangeal joint contracture during passive extension) will be assessed using low energy computed tomography before treatment, 3 months and 36 months after treatment for blinded assessment. Furthermore, in addition to the clinical follow-up, the patient will be followed by a blinded assessor. At each follow-up visits with the blinded assessor, patient will be asked to wear white opaque gloves to ensure the blinding for the treatment during assessment including the main outcome. Clinicians, nurses and patients will be instructed to the importance of avoiding communication about the treatment to the blinded assessor.
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 old
- •Ascertained Dupuytren disease: palpable fibrotic nodule or cord developed from the palmar aponeurosis, flexion contracture of a metacarpophalangeal or proximal interphalangeal joint.
- •Presence of at least one flexion contracture of a metacarpophalangeal joint of the hand due to Dupuytren's disease and > or = 20°
- •Written informed consent signed by the patient
- •Patient affiliated to the social security
排除标准
- •Presence of other musculoskeletal disorders of the hand than Dupuytren's disease: known inflammatory rheumatic disease of the hand, clinical signs of inflammatory rheumatic disease of the hand, MP or PIP pain at inclusion visit.
- •Previous surgery of the hand to be treated resulting in functional limitation or limitation of finger mobility
- •Any other pathological condition or limited range of motion in the finger to be treated
- •Psychiatric status precluding patient evaluation; vulnerable persons; adults under legal protection order or incompetent, physically or mentally incapable of giving his consent.
- •Pregnant or beastfeeding women
- •Participation in another interventional trial
结局指标
主要结局
Metacarpophalangeal joint contracture during passive extension
时间窗: at 3 months after treatment
Expressed in degrees, using low energy computed tomography for blinded assessment (computed tomography imaging will be analysed by a blinded assessor not involved in the treatment). Baseline will be Metacarpophalangeal joint contracture during passive extension the day of the treatment, before any treatment
次要结局
- Main metacarpophalangeal joint contracture during passive extension,(at 36 months after treament)
- The functional limitation using Quick DASH questionnaire(at 1 week, 1, 3, 12, 24 and 36 months after treatment)
- Metacarpophalangeal joint contractures during passive and active extension(at 1 week, 1, 3, 12, 24 and 36 months after treatment)
- The clinical success(at 3 months after treament)
- The interphalangeal joint contractures during passive and active extension(at 1 week, 1, 3,12, 24 and 36 months after treatment)
- The patient satisfaction on a 0-100 mm visual analog scale(at 1 week, 1, 3, 12, 24 and 36 months after treatment)
- Complications and adverse events for secondary treatment(at the treatment time, at 12, 24 and 36 months;)
- The recurrence(at 12, 24 and 36 months after treament)
- The 70% improvement from baseline of the flexion contracture(at 1 week, 1, 3, 12, 24 and 36 months after treatment)
- The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints(at 1 week, 1, 3, 12, 24 and 36 months after treatment)
- The URAM scale(at 1 week, 1, 3, 12, 24 and 36 months after treatment)
- Complications and adverse events for primary treatment(at the treatment time, and at 1 week, 1, 3, 12, 24 and 36 months;)
- The post-interventional pain and needs(at 1 week, 1, 3, 12, 24 and 36 months)
- The number of secondary and repeated treatments(at 12, 24 and 36 months after treatment)