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临床试验/NCT07186829
NCT07186829尚未招募不适用

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.

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2025年11月30日最近更新:
适应症
干预措施

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

Active Comparator

closed reduction, two percutaneous pins

干预措施: Percutanous pinning (Device)

Locked plate

Active Comparator

open reduction, dorsal approach, 3 screws proximal and distal

干预措施: Locked plate (Device)

Intramedullary screw

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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