CTRI/2023/05/052392已完成不适用
A Retrospective, Observational, Post-Marketing Study to Evaluate the Functional Outcomes in Patients Who Underwent Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction Using Sironix Suture Button and Peek Button.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the function of the knee post ACL reconstruction
研究概览
简要总结
Arthroscopy implants are used for fixation of the ACL grafts at the femoral and tibial sides. Numerous grafts in terms of fixed suture button, adjustable loop suture button, and interference screws made up of multiple materials will be used for the fixation. In this study, we would want to evaluate the functional outcomes in patients who underwent arthroscopic ACL reconstruction using Sironix suture button and Peek button. The available Patient data will be collected and assessed to evaluate the safety and effectiveness of the Sironix knee implant device.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male/ Female Patients of 18 to 60 years of age.
- •2.Patients who underwent arthroscopic anterior cruciate ligament (ACL) reconstruction using the Sironix suture button and Peek Button between the period of August 2022 to January
- •3.Patient willing to give written informed consent to participate in the study when attending an in-clinic follow-up visit, or providing verbal consent during the telephonic follow-up visit.
排除标准
- •1.Patients not responding to calls after three attempts and not interested to participate in the study.
- •2.Patients with injury to the same knee post ACL reconstruction procedure.
结局指标
主要结局
To evaluate the function of the knee post ACL reconstruction
时间窗: One follow up after EC approval 6months to 3.5 years after surgery
次要结局
- 1)To assess the level of activity post ACL reconstruction(2)To assess the quality of life after ACL reconstruction)
研究者
研究点 (1)
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