Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Clinical Outcome - Shoulder function
研究概览
简要总结
The primary objective of the study is to evaluate the functional shoulder recovery of patients with recurrent shoulder dislocations at 24 months when treated with either arthroscopic capsuloligamentous repair (Bankart Procedure +/- Remplissage) or coracoid transfer (Latarjet procedure).
详细描述
Background:
Shoulder is a highly mobile joint with the most directional range of movement compared to other joints in the body. Thus, the surrounding supporting structures of the shoulder joint compromise on the stability of the joint, in order to accomplish this wide range of motion.
Anterior dislocations, the most common type of shoulder dislocation, are often complicated by instability, and repeated dislocations. Shoulder instability results in pain and negatively impacts quality of life. Several long-term studies have demonstrated a relationship between the repeated dislocations and the risk of arthritis.
Surgical stabilization of the shoulder improves function and may reduce the risk of developing degenerative arthritis. Two procedures are commonly performed in patients with repeated dislocations: a bony transfer procedure (Latarjet) or a soft tissue procedure (Bankart + Remplissage). The Latarjet procedure involves transferring bone to the front of the shoulder. The Bankart + Remplissage procedure involves tightening the soft tissues at the front of the shoulder joint.
Although retrospective clinical studies have suggested a reduced recurrence rate with the Latarjet procedure, there is a higher reported complication rate and potential morbidity associated with the open procedure. Several case series from high-volume surgeons in Europe have suggested the Latarjet repair to be an acceptable and potentially favorable surgical approach for all cases of recurrent anterior shoulder dislocation, even in the primary setting and in the absence of significant glenoid cup bone loss. Retrospective analysis of soft tissue repair in comparison to open coracoid (Latarjet) procedure found at 10-year follow up, redislocation rates were 13% (36) of 271 shoulders with a Bankart repair and 1% (1) of the 93 shoulders with a Latarjet repair.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18-50 years;
- •Diagnosis of post-traumatic recurrent anterior dislocation. This will require a minimum of 2 episodes of documented dislocations either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms;
- •Subcritical glenoid bone loss as defined on CT by standardized and reproducible best-fit circle technique (>10% but <20%);
- •Provision of informed consent.
排除标准
- •Patients with concomitant injuries of the index shoulder (cuff tear, greater tuberosity fracture);
- •Previous shoulder surgery;
- •Patients that will likely have problems, in the judgment of the investigators, with maintaining follow-up;
- •Epilepsy/seizure disorder;
- •Patients who are currently incarcerated;
- •Diagnosis of multidirectional instability;
- •Cases involving litigation or workplace insurance claims (e.g. WSIB);
- •Confirmed connective tissue disorder (Ehlers-Danlos, Marfans) or Beighton hypermobility score >
结局指标
主要结局
Clinical Outcome - Shoulder function
时间窗: 2 years
The change from baseline to 24 months post-intervention difference in Western Ontario Shoulder Instability Index (WOSI) scores between patients with recurrent dislocations treated with Bankart Procedure + Remplissage versus Latarjet procedure.
次要结局
- Rate of participants that return to previous level of activity(2 years)
- Rate of Recurrence(2 years)
- Clinical Outcome(2 years)
- Rate of participants with full range of motion(2 years)
- Clinical Outcome - Quality of Life(2 years)
- Rate of participants with anterior shoulder instability(2 years)
- Clinical Outcome - Shoulder activity(2 years)
- Rate of major and minor shoulder-related complications and serious adverse events(2 years)
研究者
Moin Khan
Associate Professor and Orthopaedic Surgeon
McMaster University