NCT01998048Unknown不适用
Operative Treatment of Traumatic Anteroinferior Shoulder Instability in Young Male Patients. The Outcome of Arthroscopic Bankart vs. Open Latarjet Stabilization Surgery, a Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- recurrence of instability
研究概览
简要总结
Glenohumeral joint is prone to instability, i.e. the humeral head may dislocate off the scapular glenoid plate especially in the anteroinferior direction. Surgical treatment of shoulder instability aims at restoration of shoulder stability. The purpose of this trial is to investigate the difference in outcome after arthroscopic Bankart operation compared with open Latarjet operation in the treatment of a residual instability after a traumatic primary dislocation in young males.
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 25 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subluxation or fear of shoulder dislocation after a previous, reduced and primarily conservatively treated (for more than 3 months) traumatic anteroinferior shoulder dislocation, or redislocation after a primary shoulder dislocation.
- •Clinically documented anteroinferior instability (ie. a positive apprehension and relocation test (Jobe)).
- •X-ray (true ap, 30 degrees oblique ap, Y- and axillary projections), 2- and 3-dimensional computed tomography (2D and 3D CT) and magnetic resonance imaging arthrography (MRA) documentation of the joint.
- •Congruency of the shoulder joint on imaging investigations.
- •Young adult male patient 16-25 years of age (15 years < patient < 26 years ).
- •Patient's willingness for operative treatment.
- •Written informed consent from participating subject.
排除标准
- •Non-congruency of the glenohumeral joint on imaging investigations.
- •Concomitant dislocated fractures (requiring operative treatment) of the humerus or the scapula (other than Hill-Sachs lesion or bony Bankart lesion)
- •Severe grade 2 or above (Samilson et Prieto) osteoarthrosis of the glenohumeral joint detected in X-ray investigation.
- •A humeral avulsion of glenohumeral ligaments (HAGL) detected in MRA investigation.
- •Concomitant ipsilateral plexus or axillar nerve injury affecting motor function.
- •Life threatening other concomitant injuries (i.e. multitrauma patient).
- •Stiffness of the glenohumeral joint (restricted passive external rotation less than 30 degrees measured in standing position, arm at side).
- •Age under 16 or above 25 years.
- •Open physis with significant growth expectation.
- •Intellectual disability, history of seizures with high risk of recurrence, existing significant malignant, haematological, endocrine, metabolic, or rheumatoid disease.
结局指标
主要结局
recurrence of instability
时间窗: 5 years
The recurrence of instability (re-dislocation, subluxation, positive apprehension) is used as a primary outcome measure together with WOSI score two and five years postoperatively.
次要结局
未报告次要终点
研究者
Ville Aarimaa
adjunct professor
Turku University Hospital
研究点 (8)
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