NCT01111500Unknown不适用
First Time Anterior Glenohumeral Joint Dislocation With a Bankart Lesion in Young Patients: Which Type of Immobilization Should be Chosen? A Prospective Randomized Study
Hopital de l'Enfant-Jesus2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Anatomical healing of the labrum
研究概览
简要总结
Glenohumeral joint dislocation is the most frequent joint dislocation with a prevalence of 1.7/100000 citizens/year. It is treated by reduction, under sedation or anaesthesia, followed by an immobilization of the arm.
The purpose of the study is to evaluate the healing of the labrum in first time anterior glenohumeral joint dislocation with a Bankart lesion in young patients by comparing an external rotation brace to an internal rotation brace to immobilize the injured arm.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old
- •< 40 years old
- •anterior glenohumeral joint dislocation proved by radiography
- •dislocation needing a reduction manoeuvre
- •home close to evaluation site for 24 months follow-up visits
- •signed consent form
排除标准
- •associated fracture
- •Hill-Sachs lesion = or > than 30%
- •neurovascular deficit
- •hypermobility
- •pre-existing instability of the injured shoulder
- •systemic neurological disease
- •allergy to gadolinium
- •functional sequel to the shoulder due to previous injury
- •incapacitated adult patient
- •minor patient
- •home far from evaluation site
- •refusal to sign the consent form
结局指标
主要结局
Anatomical healing of the labrum
时间窗: 3 months after dislocation
An MRI with usual cuts in ABER and ADIR positions are performed to demonstrate the anatomical healing of the labrum.
次要结局
- Decrease in relapse rate(24 months after dislocation)
研究者
Pelet Stephane
Dr Stephane Pelet MD, PhD Orthopedic surgeon
Hopital de l'Enfant-Jesus
研究点 (2)
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