NCT04186481已完成不适用
Safety and Performance of MINITAC◊ Ti 2.0 Suture Anchor in Extremities
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative
研究概览
简要总结
This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.
详细描述
Up to 3 sites will participate in the study across Australia and the EU, collectively enrolling a minimum of 30 and a maximum of 50 subjects into the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Subject has undergone extremities repair using the MINITAC◊ Ti 2.0 Suture Anchor.
- •Subject was ≥ 18 years of age at time of surgery.
- •Subject status is > 12 months post-operative.
排除标准
- •Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
结局指标
主要结局
Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative
时间窗: 6 months
Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon.
次要结局
- Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
Comparison of efficacy of Mitek mini anchor suture technique with conventional technique for treatment of jaw joint pain due to malpositioned discCTRI/2018/05/013736Dr Jithin P
已完成
不适用
Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptomite) in ExtremitiesMedial or Lateral Instability Repairs/ReconstructionsHallux Valgus RepairsAchilles Tendon Repairs/ReconstructionsMidfoot ReconstructionsMetatarsal Ligament/Tendon Repairs/ReconstructionsBunionectomyScapholunate Ligament ReconstructionsUlnarLateral Epicondylitis RepairBicep Tendon ReattachmentsNCT03782298Smith & Nephew, Inc.122
已完成
1 期
Clinical evaluation of a novel suture anchor for rotator cuff repairs – ATOK AnchorACTRN12617000800325Assoc Prof Michael Sandow15
招募中
不适用
Clinical Performance and Safety of Suture-TOOLLaparotomyClosure TechniqueWound InfectionIncisional HerniaNCT05695157Suturion AB38
已完成
不适用
Performance and Safety of the FIXIT® Anchor in Arthroscopic Rotator Cuff RepairRotator Cuff InjuriesNCT05720286Science and biomaterials30