Change of Strength and Range of Motion in Arthroscopic Latarjet Procedure - A Prospective Trial Involving the Four Muscles Altered
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Strength
研究概览
简要总结
Open and arthroscopic Latarjet procedures are used to treat shoulder instability as primary and salvage procedures. During surgery the coracoid process is detached and repositioned to the anterior glenoid through a subscapularis split and fixed in place, resulting in an enlarged glenoid and therefor articular surface. However, before this is done, the pectorals minor, which inserts at the coracoid process, has to be detached and is left without further treatment. Moreover, the conjoint tendon, the origin of the short head of the biceps and coracobrachialis, is repositioned with the coracoid and therefor distalized and medialized.
No study currently followed up on the strength of the muscles altered. The aim of this study is therefor, to prospectively measure range of motion and strength of the operated shoulder at different time points pre- and postoperatively, comparing it with the healthy shoulder in each individual.
详细描述
Strength, range of motion and stability will be assessed pre-operatively and at 6 weeks, 12 weeks, 6 months, 12 months and 24 months post-operatively. Next to standard radiological follow up, including X-ray, arthrographic computed tomography as well as arthrographic magnetic resonance imaging, specific shoulder scores will be utilised. Strength for general shoulder motion as well as specifically for the subscapularis, the pectorals minor, the coracobrachialis and the biceps will be measured with a shoulder dynamometer. Data will be analysed and published.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who experienced at least one shoulder dislocation.
- •Patients who are willing to participate in the study
- •Patients who receive arthroscopic Latarjet procedure for treatment of glen-humeral instability
- •Patients who are at least 18 years old.
- •Patients with an ISI-Score of at least 4 points.
排除标准
- •Patients older than 50 or younger than 18 years of age.
- •Patients with painful unstable (multidirectional) instability
- •Patients with congenital defects of the bones involved (humerus, scapula).
- •Patients with an ISIS of smaller 4 points.
结局指标
主要结局
Strength
时间窗: 24 months
Strength for different muscles involved in shoulder movement is measured pre- and post-operatively for the operated shoulder and the contralateral side. Strength will be measured in Kilogramm with a shoulder dynamometer. Scale range is assumed to be between 0 and 25 kg, higher values postoperatively indicate better outcome. Measurements will be undertaken for the subscapularis in internal rotation at 0 and 90 degrees; for the muscles attached to the conjoint tendon (short head of the biceps and coracobrachialis) in 45 degree shoulder flexion, while resistance will be applied on the flexing forearm. The pectoralis minor measurment will be undertaken through applying pressure against the protracting shoulder. Furthermore, standard strength measurements will be undertaken in 90 degree shoulder flexion and abduction, applying resistance against the hand, and in 0 degree internal as well as external rotation with a flexed elbow.
次要结局
- Range of Motion(24 months)
- Stability(24 months)
研究者
Daniel Smolen, MD
MD
Etzel Clinic