跳至主要内容
临床试验/NCT03773848
NCT03773848Unknown不适用

Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle

Assiut University0 个研究点目标入组 30 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Improvement of limb function this change will be assessed using Disabilities of the Arm, Shoulder and Hand (DASH) Score as limb function will be expected of some movement limitation at 6 weeks and no limitations to be at 6 months

研究概览

简要总结

to compare the clinical & radiological outcomes of hook plate & tightrope fixation in fracture of lateral third clavicle.

详细描述

Adult clavicle fractures account for 4% to 10% of fractures. Distal clavicle fractures occurs in 25% to 30% of all clavicle fracture.The management of fractures of the distal clavicle has been a matter of debate in literature. Neer in 1968 suggested a new classification and proposed general treatment guidelines . Type I and type III fractures are generally treated non-operatively. For type II fractures, surgical management is the treatment of choice .There are numerous operative techniques reported in the past. The methods of surgical treatment could be summarised as follows:

  1. Fixation in terms of K-wires and different pins such as the Steinmann pin, and Knowles pin. This fixation could also be augmented with concomitant tension band wires
  2. Coracoclavicular indirect fixation with the use of screws, suture anchors, Dacron graft or Mersilene tape
  3. Open reduction and clavicular plate fixation with the use of different plate systems such as the Balser plate,locked plate,hook plate, etc.

Different surgical techniques have their own advantages and disadvantages With more than 20 techniques described so far, no single fixation is ideal and perfect. There is still no consensus regarding the best surgical method to fix these fracture ,the investigators choose two of the most common of these methods and evaluate & compare best radiological & clinical outcomes of both.

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
Single (Participant)

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (over 16 years old) including both sexes.
  • Acute fractures within 3 weeks of injury.
  • Isolated & closed fractures.

排除标准

  • Pathological fracture of distal clavicle.
  • Deteriorated general health.
  • Previous history of dysfunction with the affected shoulder.
  • Incomplete medical records or lost to follow up.

结局指标

主要结局

Improvement of limb function this change will be assessed using Disabilities of the Arm, Shoulder and Hand (DASH) Score as limb function will be expected of some movement limitation at 6 weeks and no limitations to be at 6 months

时间窗: at 6 weeks & 6 months post-operatively.

The DASH is a self-administered questionnaire that consists of thirty core questions and an optional additional eight questions assessing work and sports and/or performing arts activities. Each individual item is scored on a 5-point Likert scale, with lower scores correlating to minimal impairment and higher scores indicating more impairment. The cumulative DASH score is scaled from 0 to 100, with higher scores indicating more disability

次要结局

  • Fracture Healing(at 6 weeks & 6 months post-operatively.)
  • Skin condition(at 6 weeks)
  • Radiation time(Intra-operatively)
  • Blood loss(Intra-operatively)

研究者

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

David Mounir Kamal Ibrahim

Principal Investigator

Assiut University

相似试验