跳至主要内容
临床试验/NCT03607045
NCT03607045Unknown不适用

Headless Screws Versus Bouquet in Intramedullar Fixation of Boxer's Fracture: A Randomized Clinical Trial

Faculdade de Medicina do ABC2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
2
主要终点
patient outcome reported

研究概览

简要总结

Despite the high prevalence (20% of the hand fractures) of unstable neck metacarpals fractures (boxer's fractures) there is still no consensus concerning the preferred method and ideal moment of treatment, especially in active patients where the time or type of management can have a strong psychological impact on the outcomes.

The use of intramedullar technique (headless intramedular screws or bouquet technique fixation) as definitive treatment of unstable boxer's fractures in active patients at the first week, may be a good choice of treatment. This technique is fast, safe, minimally invasive and easily performed reproducible method, without address the extensor tendon to prevent tendon adhesion and joint stiffness, unable earlier functional recovery and shorten the working return time of these patients. Choose a reproducible and effective method, which presents a cost / benefit compatible with our reality.

The goal of the present study is to compare working return time, VAS (visual analogue score), quick DASH (disability arm, shoulder and hand) and radiographic outcomes of two methods of definitive internal fixation in active patients in boxer's fractures, operated in the first week.

详细描述

A double center, parallel group, prospective, randomized clinical trial was conducted at the department of Hand Surgery, ABC University hospital, Santo Andre, Brazil and Hospital Mãe de Deus, Porto Alegre, Brazil. Two implants used for fixation in closed reduction of boxer's fractures were compared: the headless cannulated screws (Synthes®, Davos) and the Bouquet technique with k-wires (Synthes®, Davos). The protocol was approved by the local research ethics committee. All patients received, signed and are aware of what was recommended in the Informed Consent (IC). Inclusion criteria were; presence of an acute (0 to 7 days), closed and simple fracture of the metacarpal neck, absence of an ipsilateral injury or deformity, Start January 2017.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • presence of an acute (0 to 7 days), closed and simple fracture of the metacarpal neck, absence of an ipsilateral injury or deformity, presence of an angulation of over 40 degrees in oblique plane imaging, being 18 years of age or older, having acquired a master's degree or still being a student, and being an employee in a social-professional environment with mild physical activities.

排除标准

  • elderly, children, mental ness

结局指标

主要结局

patient outcome reported

时间窗: 6 months

QuickDASH

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

Marcio Aurelio Aita

Affiliated Professor

Faculdade de Medicina do ABC

研究点 (2)

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