2024-515110-40-00招募中3 期
DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomized, controlled, outcome assessor-blinded, three armed parallel 1:1:1, multicenter trial comparing efficacy and cost effectiveness of collagenase clostridium histolyticum, percutaneous needle fasciotomy and limited fasciectomy as a short and long term treatment strategy in mild or moderate Dupuytren’s contracture
Pirkanmaan hyvinvointialue, Pirkanmaan hyvinvointialue6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月3日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Success at five years
研究概览
简要总结
To determine, which treatment strategy 1) primary PNF followed by surgical LF in patients who do not respond to PNF, 2) primary CCH followed by surgical LF in patients who do not respond to CCH or 3) LF as the primary (and secondary) treatment modality is the most efficacious and cost-effective in treating DC in 5-year follow-up.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •patients with at least 20° combined extension deficit in metacarpophalangeal joint (MP) and/or proximal interphalangeal joint (PIP) in finger/fingers II-V 2) age > 18 years 3) palpable cord 4) provision of informed consent 5) ability to fill the Finnish versions of questionnaires
排除标准
- •recurrent contracture in the finger to be treated 2) neurologic condition causing the loss of function of the finger to be treated 3) contraindication for collagenase clostridium histolyticym (Xiapex/Xiaflex ®) 4) pregnant or breast feeding 5) TPED > 135° (Tubiana stage 472) in finger to be treated 6) rheumatoid arthritis 7) previous fracture in finger to be treated, which affects range of motion of MP or PIP joint 8) age > 80 years
结局指标
主要结局
Success at five years
Success at five years
次要结局
未报告次要终点
研究者
Olli Leppänen
Scientific
Pirkanmaan hyvinvointialue
研究点 (6)
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