Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Recurrence rate
研究概览
简要总结
Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer
- •DC of either II-V finger
- •Well-defined/palpable cord
排除标准
- •Legally incapacitated
- •Previous study inclusion with another finger ray
- •Isolated proximal interphalangeal (PIP) or distal interphalangeal (DIP) joint contracture, defined as MCP joint contracture < 20° PED regardless of the deficit in the PIP or DIP joint
- •Previous hand surgery of the affected finger for any reason
- •Known allergy to the study medication
- •Anticoagulant therapy (Acetylsalicylic acid is NOT an exclusion criterion)
- •Pregnant or lactation
- •Insulin dependent diabetes mellitus
- •Ongoing systemic infection or local infection at the site of the procedure
- •Rheumatoid arthritis
- •Amyloidosis or mucopolysaccharidosis
- •Unable to communicate, cooperate or participate in follow-up
研究组 & 干预措施
Corticosteroid injection
Percutaneous needle fasciotomy with corticosteroid injection
干预措施: Percutaneous needle fasciotomy (Procedure)
Corticosteroid injection
Percutaneous needle fasciotomy with corticosteroid injection
干预措施: Corticosteroid injection (Drug)
Saline injection
Percutaneous needle fasciotomy with saline injection
干预措施: Percutaneous needle fasciotomy (Procedure)
Saline injection
Percutaneous needle fasciotomy with saline injection
干预措施: Saline injection (Other)
结局指标
主要结局
Recurrence rate
时间窗: 2 years
Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline
次要结局
未报告次要终点
研究者
Laura Houstrup Matthiesen
Medical Student, PhD Student
Regionshospitalet Silkeborg