Return to Sport and Functional Performance Following Surgical Intervention for Anterior Glenohumeral Instability (AGHI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Shoulder dislocation and recurrence
研究概览
简要总结
The purpose of this prospective cohort study is to compare patient-reported, clinical, and functional outcomes in patients who have elected to have either the Bankart with Remplissage or Latarjet procedure for the treatment of anterior glenohumeral instability (AGHI) up to 24-months postoperative.
详细描述
The purpose of this prospective cohort study is to compare patient-reported, clinical, and functional outcomes in patients who have elected to have either the Bankart with Remplissage or Latarjet procedure for the treatment of AGHI up to 24-months postoperative. A secondary objective aims to address rates of return to sport (RTS) and performance in an RTS assessment in athletic patients with anterior glenohumeral instability (AGHI) who elect to undergo either surgical intervention until 24-months postoperative.
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
- •Aged 18 - 50 years
- •Documented reduction of anterior shoulder dislocation
- •Patient has suffered two or more dislocations of the study shoulder
- •Physical examination elicits unwanted glenohumeral translation with reproduction of symptoms
- •Glenoid bone loss defined on CT (or MRI) using standardized and reproducible best-fit circle techniques < 25%
- •Able to benefit from surgical intervention
排除标准
- •Glenoid defect in the affected shoulder ≥ 25% of the AP diameter of the glenoid
- •Previous surgery on affected shoulder (ANY type of shoulder surgery)
- •Significant shoulder comorbidities including osteoarthritis or other shoulder conditions including multi-directional instability
- •Participant is involved in litigation or a workplace insurance claim (i.e., WCB).
- •Confirmed connective tissue disorder (i.e., Ehlers-Danlos, Marfans)
- •Beighton hypermobility score of >6
- •Active joint or systemic infection, significant muscle paralysis, rotator cuff tear arthropathy, Charcot's arthropathy, significant medical comorbidity that could alter the effectiveness of the surgical intervention (e.g., Cervical radiculopathy, polymyalgia rheumatica)
- •Major medical illness (life expectancy less than 1 year) or unacceptably high operative risk
- •Any condition that precludes informed consent (i.e. psychiatric illness)
- •Unable to speak or read English/French
- •Unable or unwilling to be followed for 2 years or complete functional testing
结局指标
主要结局
Shoulder dislocation and recurrence
时间窗: 24 months
Dislocation requiring reduction by a physician (ED) or surgery. Dislocations will be identified in two ways: 1) if the patient seeks treatment from the surgeon, the surgeon will notify the research coordinator who will document it accordingly, or 2) at each research postoperative examination, the research staff will ask patients if they experienced a dislocation or subluxation. These will be considered alongside the definition of recurrence from Kasik et al. that also includes subluxation, or positive findings during physical examination for shoulder instability (apprehension).
Western Ontario Shoulder Instability Index (WOSI)
时间窗: 24 months
Is a disease specific, quality of life patient reported outcome measures (PROMS) for patients with shoulder instability. Patients use visual analog scales (VAS) to rate physical symptoms and impacts of the condition/treatment on sports/recreation/work, lifestyle, and emotions.
Surgical complications, re-operations and revision surgeries
时间窗: 24 months
Surgical complications will be documented at the time of surgery and at each postoperative interval. A surgical complication is defined as any undesirable, unintended and direct result of an operation affecting the patient that would not have occurred had the operation gone well as could reasonably be hoped (Sokol and Wilson, 2008) (i.e., infection, dislocation, neurological injury, and fracture (including periprosthetic and acromial fracture). Revision surgery and re-operations will be documented, including the reason for failure, date of revision/reoperation, and the procedure performed. Revision is defined as a change of an original component (partial or complete replacement). Re-operation is defined as any surgical procedure other than a revision.
次要结局
- Posterior Shoulder Endurance Test(24 months)
- Athletic Shoulder (ASH) Test(24 months)
- Isokinetic Internal and External Rotation(24 months)
- Seated medicine ball toss(24 months)
- Plyometric Push up(24 months)
- Single arm seated shot put(24 months)