The Arthroscopic Treatment of Recurrent Anterior Shoulder Instability: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- WOSI Score
研究概览
简要总结
The objective of this study is to investigate arthroscopic treatments of recurrent anterior shoulder instability. Functional outcomes of arthroscopic anatomic glenoid reconstruction with bone graft will be compared to the gold standard, arthroscopic Bankart repair. The investigators hypothesize that arthroscopic anatomic glenoid reconstruction with bone graft will provide better functional outcomes and decreased risk of recurrent dislocation/subluxation.
This will be a single center, double blinded, randomized controlled trial performed in Halifax, Nova Scotia, Canada. The primary outcome measured will be the Western Ontario Shoulder Instability (WOSI) score. Secondary outcomes will be subluxation, re-dislocation, and range of motion. A minimum of 200 patients will be enrolled in the study as determined by sample size calculation. Routine radiographs as well as a pre-operative CT with 3D reconstruction and MRI are obtained for all patients. The patients will then undergo a clinical examination and complete a variety of functional and quality of life surveys. Randomization will be based on surgeon skill. Two groups (Bankart repair and anatomic glenoid reconstruction) will be selected with 100 subjects each. Postoperatively, patients in both groups will follow a standardized rehabilitation protocol. The patient will follow-up with the attending surgeon at 2 weeks post-operatively for a wound check. At the 3, 6, 12, and 24 month visits the patient will again undergo the structured clinical examination conducted by a physiotherapist who is blinded to the patients' treatment group. The patient will also complete the questionnaires at each of these follow-up appointments. Complications, and subluxation/dislocation events will be documented at each follow-up evaluation. On the basis of a clinical examination and patient history, the surgeon will diagnose recurrent instability and categorize it as a traumatic or atraumatic subluxation or dislocation.
详细描述
Study Objective
The objective of this study is to investigate the outcomes of arthroscopic treatments of recurrent anterior shoulder instability. Arthroscopic bone grafting of the glenoid will be compared to the gold standard, arthroscopic Bankart repair. The investigators hypothesize that arthroscopic anatomic glenoid reconstruction with bone graft will provide better functional outcomes and decreased risk of recurrent dislocation and subluxation. The null hypothesis is that there is no difference in change in WOSI scores between arthroscopic anatomic glenoid reconstruction and the current standard treatment, arthroscopic Bankart repair, at two years of follow up in patients with recurrent shoulder dislocation.
Subject Selection
The objective of this study is to determine if glenoid bone grafting provides superior functional outcomes as determined by WOSI score to Bankart repair in patients with anterior shoulder instability. This will be a single center, double blinded, randomized controlled trial of a minimum of 200 patients performed at the Halifax Infirmary, Queen Elizabeth II Health Sciences Centre in Halifax, Nova Scotia, Canada. The primary outcome measured will be WOSI score. This is a validated measure assessing quality of life in patients with this condition. Secondary outcomes will be subluxation, re-dislocation, strength and ROM, and other validated functional outcome scores, including: the VR-12 questionnaire, the DASH questionnaire, and the Marx Shoulder Activity Scale (appendix). The ISIS (instability severity index score) (appendix) score will be calculated.
The Western Ontario Shoulder Instability Index (WOSI) is a tool designed for self-assessment of shoulder function for patients with instability problems. It is a disease specific quality of life score. Its high sensitivity makes it able to monitor an individual patient's progress. The WOSI score has good validity (0.768), a high degree of reliability (0.911), and a high degree of responsiveness.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 or more documented incidences of anterior glenohumeral dislocation
排除标准
- •Uncontrolled diabetes (Hgb A1C >7%
- •Prior surgery of affected shoulder
- •Pregnancy
- •Multidirectional instability
- •Posterior instability
- •Paralysis of the shoulder
- •Severe systemic illness
结局指标
主要结局
WOSI Score
时间窗: 2 years
Western Ontario Shoulder Instability (WOSI) is being used as a disease-specific outcome measure.
次要结局
- Recurrent Instability(2 years)
研究者
Ivan Wong, MD
Dr. Ivan Wong
Nova Scotia Health Authority