Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device KF 23)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Fusion time of bone in distal interphalangeal arthrodesis of the fingers
研究概览
简要总结
Arthrodesis of a distal interphalangeal joint of the finger (DIP) is mainly performed for a degenerated and painful joint. Various stabilization methods have been used to provide compression at the arthrodesis site such as pins, steel wires, compression screws, headless compression screws, bioresorbable implants and intramedullary staples.
Although with complications such as implant fractures or dorsal cortical erosion, intramedullary arthrodesis staples provide reliable pain relief and a consistent fusion rate while inevitably scarring the finger pulp or nail dystrophy.
The aim of this study is to evaluate the bone fusion time during an arthrodesis performed with the Kerifuse shape memory implant.
详细描述
Arthrodesis of a distal interphalangeal joint of the finger (DIP) is mainly performed for a degenerated and painful joint. Various stabilization methods have been used to provide compression at the arthrodesis site such as pins, steel wires, compression screws, headless compression screws, bioresorbable implants and intramedullary staples.
Although with complications such as implant fractures or dorsal cortical erosion, intramedullary arthrodesis staples provide reliable pain relief and a consistent fusion rate while inevitably scarring the finger pulp or nail dystrophy.
The aim of this study is to evaluate the bone fusion time during an arthrodesis performed with the Kerifuse shape memory implant.
Main objective is to evaluate the bone fusion time in arthrodesis performed with the Kerifuse shape memory implant.
Secondary objectives are :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Eligible patients with osteoarthritis of finger for an interphalangeal arthrodesis with KeriFuse implant
排除标准
- •Pregnant or breastfeeding patient
- •Patient with an intellectual disability and who therefore cannot follow the surgeon's instructions
- •Patients with contraindications to surgery
- •Patients with acute or chronic, local or systemic infections
- •Patients with sensitivities or allergies to device components (Nickel, Titanium)
研究组 & 干预措施
Patients
Patients older than 18 years-old, with a surgical indication of interphalangeal arthrodesis of finger
干预措施: KeriFuse implant implantation (Procedure)
结局指标
主要结局
Fusion time of bone in distal interphalangeal arthrodesis of the fingers
时间窗: day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery
Fusion time of bone (in weeks) will be measure by X-ray,
次要结局
- Patient satisfaction(D5 - W4 - W6 - W8 - W10 - W12 - Y2 after surgery)
- Evaluation of global hand function(day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery)
- Evaluation of arthrosis degree(day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery)
- Mid-term efficacy of arthrodesis in pain decrease(day 5 - week 4 - week 6 - week 8 - week 10 - week 12 - year 2 after surgery)