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临床试验/NCT07509437
NCT07509437已完成不适用

Cons and Pros of Concomitant Carpal Tunnel Release During Distal Radius Fracture Fixation

Benha University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Frequency of Symptomatic Carpal Tunnel Syndrome

研究概览

简要总结

This randomized study evaluates the impact of performing a prophylactic carpal tunnel release (CTR) at the same time as surgical fixation for a distal radius fracture (DRF). The study compares this simultaneous approach against a postponed approach (observing and only performing CTR if symptoms develop) to determine which strategy better reduces the frequency of re-operation and improves functional outcomes.

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

盲法说明

Both the investigators and the participants are aware of which arm the patient has been assigned to.

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients presenting with trauma to the lower end of the radius requiring surgical intervention.
  • Fractures classified as AO/OTA classes involving significant displacement, articular surface depression, or comminution (excluding simple A-C1 classes).

排除标准

  • Simple fractures (AO/OTA class A-C1) suitable for non-operative management.
  • Pre-existing neurocognitive or psychological disorders.
  • Refusal to participate or sign written consent.

研究组 & 干预措施

Simultaneous CTR

Active Comparator

干预措施: Carpal tunnel release (Procedure)

Simultaneous CTR

Active Comparator

干预措施: Distal Radius Fracture Fixation with Observation. (Procedure)

Postponed CTR)

Active Comparator

干预措施: Distal Radius Fracture Fixation with Observation. (Procedure)

结局指标

主要结局

Frequency of Symptomatic Carpal Tunnel Syndrome

时间窗: From surgery through the completion of fracture healing (4-6 wks)

The number of patients who develop symptomatic median nerve compression requiring medical or surgical intervention after the initial fracture correction.

次要结局

  • Postoperative Functional Status of the Upper Extremity.(5-10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adel Samy ElHammady

Lecturer of Orthopedic Surgery, Faculty of Medicine, Benha University.

Benha University

研究点 (1)

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