A Randomized Controlled Trial (RCT) Comparing Clostridium Histolyticum With Needle Aponeurotomy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reduction in Total Passive Extension Deficit
研究概览
简要总结
Aim:
Clinical RCT comparing functional results and recurrence rate following enzymatic treatment vs. needle aponeurotomy.
Materials and methods:
30° or more contracture of only one metacarpophalangeal (MCP) joint contracture of one of the three ulnar digits and less than 20° for the adjacent proximal interphalangeal (PIP) joint. Patients with primary disease of the hand. Total of 80 patients needed to detect difference of 13.5°.
- Needle aponeurotomy 2) Clostridium Histolyticum treatment. Clinical follow ups 1,4 weeks, 16 weeks and 1,2 and 5 years. Functional outcome scores: URAM, Quick Dash, EQ5D, brief MHQ, VAS pain and VAS patient satisfaction. Total passive extension contracture reduction, recurrence rate and registration of complications.
详细描述
Open surgery (fascieectomy) has traditionally been considered the gold standard of treatment for Dupytren´s disease (Dd) despite considerable risk of complications.
There is an increasing interest in Scandinavia in the treatment of Dd with Clostridium Histolyticum (Xiapex ®, Auxillium). However the enzyme is expensive and long-term effects are not well documented. More studies are needed to analyze both short and long term clinical outcome as well as cost-benefit analysis.
The treatment arm of Xiapex in this study follows the recommendation as by the producer.
The other treatment of Dd contracture in this study is needle fasiotomy/aponeurotomy. We use multiple perforation technigue with 26 G needle needle, with as little local anesthesia (xylocin w adrenaline) as needed during contionus extension of the finger untill successfully extended.
The two procedures leave little scar tissue lessening the challenges posed by the reoperations.
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
- 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
- 是
入选标准
- •Primary Dd disease (no earlier treatment for this condition of the hand involved)
- •Single digit involvement, one of the three ulnar digits
- •Average norwegian language skills.
- •MCPJ contracture of 30 degrees or more and less than 20 degree involvement of the adjacent PIPJ
- •Minimum 18 y.o.
排除标准
- •Involvement of 2 fingers/joints
- •Earlier treatment for Dd disease of the same hand, affection of addjecent PIPJ of 20 degrees or mor
- •Pregnancy
- •Ongoing treatment with platelet inhibitors
- •Treatment with tetracycline 2 weeks prior to treatment date
- •Poor norwegian language skills
- •Participation in other studies 4 weeks prior or after treatment date
- •"Need to treat" of both hands
研究组 & 干预措施
Needle aponeurotomy
percutaneous transection or pretendinous palmar dupytren cord
干预措施: Needle aponeurotomy (Procedure)
Xiapex
Injection of 0.58 mg collagenase into pretendinous palmar dupytren cord
干预措施: Xiapex (Drug)
结局指标
主要结局
Reduction in Total Passive Extension Deficit
时间窗: 5 years
次要结局
- EQ5D (Euroqol 5 Dimensions)(5 years)
- Quick Dash (Disabilities of the shoulder and Hand)(5 years)
- Brief MHQ (Michigan Hand Questionare)(5 years)
- URAM (Unité Rhumatologique des Affections de la Main)(5 years)
- Jamar grip strength(1,4,26 weeks and one year.)
- VAS (Visual analogue scale) pain(1,4,26 weeks and one year)
- VAS (Visual analogue sale) satisfaction(1,4,26 weeks. 1,2 and 5 years)
- Complications(1,4,weeks One year)
- Recurrence(1,4,26 weeks. 1,2 and 5 years)
研究者
Ingi Thor Hauksson
MD
University Hospital, Akershus