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临床试验/NCT07039695
NCT07039695已完成不适用

Evaluation of Union Rate of Scaphoid Non-Union Fracture in Adults by Herbert Screw Versus Volar Buttress Plate

Helwan University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年3月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Mayo Wrist Score

研究概览

简要总结

This study aimed to evaluate the short-term results of treating non-united scaphoid waist fractures with a humpback deformity by graft and internal fixation using a volar buttress plate versus the use of a Herbert screw.

详细描述

Scaphoid fracture is the most common fracture, accounting for roughly 60% of the total carpal bone fractures and 11 % of all hand fractures.

Nonunion occurs in approximately 5% to 25 % of scaphoid fractures. The scaphoid nonunion will collapse into a humpback deformity, and the lunate, together with the proximal pole, into a dorsal intercalated segment instability, which might end in an advanced carpal collapse.

A scaphoid screw acts to prevent bending at the fracture site with three-point fixation within the cancellous bone of the scaphoid. The proximal and distal points of purchase are achieved by the capture of the screw threads in the cancellous bone of the proximal and distal poles of the scaphoid. The third point occurs within the cancellous bone of the scaphoid waist.

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age of a patient is between 20 years to 50 years.
  • Non-union or delayed union scaphoid wrist fracture (more than 3 months).
  • Closed fracture.
  • Patients without previous scaphoid surgery.
  • Patients without abnormal renal and/or liver functions.
  • Patients without hypocalcemia and/or vitamin D3 deficiency.

排除标准

  • Open fracture.
  • Patients with proximal or distal fracture of the scaphoid.
  • Patients with avascular necrosis of scaphoid.
  • Patients with mid-carpal arthritis or pan-carpal arthritis.
  • Patients with carpal instability.

结局指标

主要结局

Mayo Wrist Score

时间窗: 3 months post-procedure

The Mayo Wrist Score is a fast and simple tool comprising four questions that assess pain intensity, wrist function, range of motion, and grip strength. Mayo Wrist Score ranges from 0 to 100. Scores of 90-100 are considered excellent, 80-90 good, 60-80 satisfactory, and below 60 poor.

次要结局

  • Disabilities of the Arm, Shoulder and Hand (DASH) score(3 months post-procedure)

研究者

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

Khaled Karam Abed El-Aleem Mohammed

Assistant Lecturer of Orthopedic Surgery, Faculty of Medicine, Helwan University, Egypt.

Helwan University

研究点 (2)

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