A Single-center, Non – interventional, Observational, Post market clinical follow-upstudy to assess Clinical Outcomes and Patient Reported Outcomes after treatment ofshoulder injuries using Sironix Suture Anchor Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1)To assess the clinical outcomes in the patients who underwent treatment for shoulder injuries using Sironix suture anchors
研究概览
简要总结
This study is a single center, retrospective, non interventional, observational, post market clinical follow-up study to assess clinical outcomes and patient reported outcomes after treatment of shoulder injuries using Sironix suture anchor devices. All patients who underwent treatment for shoulder injuries that includes rotator cuff tear repair or bankart repair surgery between January 2021 to December 2022 will be included in the study. Our study is aimed at investigating the efficacy and safety of the interventions used in the treatment of shoulder injuries.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Male/female patients aged ≥ 18 years and ≤ 80 years at the time of surgery 2)Patients who had undergone treatment for either rotator cuff tear repair or bankart repair with Sironix suture anchor devices with a minimum of 4 months of follow-up 3)Patients who are willing to provide written informed consent (in case of a physical visit to the site) or verbal informed consent (in case of a telephonic visit).
排除标准
- •Patients who have had any traumatic injury to the operated shoulder post surgery.
- •Patients who are not willing to attend the follow-up.
结局指标
主要结局
1)To assess the clinical outcomes in the patients who underwent treatment for shoulder injuries using Sironix suture anchors
时间窗: One follow up after EC approval, 4 months to 2.5 years after surgery
次要结局
- To evaluate the patient reported outcomes, safety of the Sironix suture anchors in the patients who underwent treatment for shoulder injuries(One follow up after EC approval, 4 months to 2.5 years after surgery)