Randomised Controlled Evaluation of the Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers: Centromedullary Screw Osteosynthesis Versus Pinning Versus Locked Plate.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Pulp-to-palm distance at 6 weeks
研究概览
简要总结
The goal of this randomized controlled trial is to compare the effectiveness, complications, and cost-effectiveness of three surgical techniques (intramedullary screw fixation, locked plating, and percutaneous pinning) for treating simple transverse extra-articular fractures of the proximal phalanges and metacarpals (excluding the thumb) in adult patients. The main questions it aims to answer are:
The primary outcome is to define which technique results in better functional outcomes, as measured by pulp-to-palm distance at 6 weeks?
The main secondary outcome is to define which technique has lower complication rates and is more cost-effective over 12 months?
Participants will be randomly assigned to one of the three surgical techniques (intramedullary screw fixation, locked plating, or percutaneous pinning). Follow-up visits at weeks: 3, 6 and months: 3,6 and final follow-up at 12 months will assess hand function, range of motion, grip strength, radiographic healing, complications, satisfaction, and costs.
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
- 否
入选标准
- •Simple transverse extra-articular fractures of proximal or diaphyseal phalanges/metacarpals with surgical indication
排除标准
- •Thumb fracture, open fracture, ischemia, pathological fracture, previous fracture, denial of consent
研究组 & 干预措施
Percutanous pinning
closed reduction, two percutaneous pins
干预措施: Percutanous pinning (Device)
Locked plate
open reduction, dorsal approach, 3 screws proximal and distal
干预措施: Locked plate (Device)
Intramedullary screw
1 cm dorsal incision, closed reduction, internal compression screw
干预措施: Intramedullary screw (Device)
结局指标
主要结局
Pulp-to-palm distance at 6 weeks
时间窗: at 6 weeks
Global range of motion measured by pulp-to-palm distance at 6 weeks
次要结局
- Range of motion(at 3 weeks, 6 weeks, 3months, 6 months and 12 months)
- Bone Healing(3weeks, 6 weeks, 3months, 6months, 12months)
- Cost analysis of each technique at 12months(12months)
- Complications(3weeks, 6 weeks, 3months, 6months, 12months)
- Grip strength(3months, 6months, 12months)
- QuickDASH PROM score(3months, 6months, 12months)
- Patient satisfaction(3months, 6months, 12months)