Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Average postoperative shoulder's pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)
研究概览
简要总结
To date, use of arthroscopic procedure to perform Latarjet procedure is still technically demanding. The benefits of arthroscopic procedure need to be evaluated compared to the mini-invasive approach. The aim of this study was to assess postoperative pain during the first week, and the positioning of coracoid bone block at the anterior aspect of the glenoid. At minimum 2 years follow-up, the recurrence of shoulder instability and functional evaluation of patients according to the Western Ontario Score Index (WOSI) were assessed.
详细描述
This prospective comparative study was performed at two centers in 2012. Each center performed one procedure so this study was observational. All patients with a chronic anterior instability requiring bone grafting (Instability Severity Index Score>3) were included. The Latarjet procedure was performed by mini-open approach (set Arthrex, Naples, FL) in the first group, and by arthroscopic approach (set Depuy-Mitek, Raynham, MA) in the second group. The analgesic postoperative protocol was standardized (paracetamol, non-steroidal anti-inflammatory, tramadol).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic anterior instability requiring bone grafting (Instability Severity Index Score>3)
排除标准
- •Patient refusal
结局指标
主要结局
Average postoperative shoulder's pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)
时间窗: Average during the first week
次要结局
- Functional evaluation of patients(2-year minimal follow-up)
- Recurrence rate of shoulder instability (number of recurrence/total number of patients)(2-year minimal follow-up)
- Mean daily pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)(Daily from day1 to day7)
- analgesic consumption (Number of pills)(Daily from day1 to day7)
- presence of postoperative discomfort symptoms (yes/no)(Daily from day1 to day7)
- coracoid bone block position to the anterior aspect of the glenoid on the anterior-posterior and the lateral X-ray and on CT-scan(Between 3 to 6 months follow-up)
研究者
Shahnaz Klouche, MD
Physician responsible of clinical research
Hospital Ambroise Paré Paris