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临床试验/NCT04482868
NCT04482868已完成不适用

Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance

Hebei Medical University0 个研究点目标入组 20 人开始时间: 2015年1月1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
20
主要终点
The modified Mayo wrist scoring system

研究概览

简要总结

The scaphoid is the most common fractured carpal bone in active adults, accounting for up to 80% of all carpal fractures. The optimum treatment approach of the acute scaphoid fractures is under discussion. Cast immobilization is the main treatment for non-displaced scaphoid fractures, however, about 20% of scaphoid fractures fail to heal with conservative treatment. Long periods of cast immobilization may result in wrist stiffness, loss of grip strength, muscle atrophy and disuse osteopenia. Operative treatment for displaced and unstable scaphoid fractures was mostly adopted, however, open fixation for scaphoid fractures have the inherent disadvantages of ligament and capsular dissection, blood vessels damage. This study introduces a novel measures of percutaneous screw fixation for acute scaphoid fractures. We used one K-wire maintaining the reduction of the scaphoid fractures throughout the entire process of drilling and screw insertion and screw fixation for acute scaphoid fractures.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •acute scaphoid fractures
  • •Injury to surgery less than 7 days
  • •Only one injured hand
  • •Written informed consent to undergo the surgical procedure
  • •Patients of either sex aged between 18 and 70 years

排除标准

  • •Patients with vascular injuried requiring revascularization
  • •Concomitant phalanx fractures or other injuries needing immobilization
  • •Loss of skin substance requiring grafts or flaps
  • •Uncompensated diabetes, neoplasia, haemocoagulative alterations, psychic disorders

研究组 & 干预措施

open reduction group

Placebo Comparator

干预措施: Percutaneous screw fixation through K-wire-assisted reduction and maintenance (Procedure)

percutaneous group

Experimental

干预措施: Percutaneous screw fixation through K-wire-assisted reduction and maintenance (Procedure)

结局指标

主要结局

The modified Mayo wrist scoring system

时间窗: 3 months

The function outcomes including pain, work status, range of motion (Rom) and grip strength were assessed and graded as excellent, good , fair and poor.

次要结局

未报告次要终点

研究者

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

Chunjie Liu

Chief physician

Hebei Medical University

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