PMCF Study on PEEK Suture Anchors for Hip Indications

Smith & Nephew, Inc.4 个研究点分布在 1 个国家目标入组 149 人2019年5月10日

适应症Soft Tissue to Bone Fixation

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Soft Tissue to Bone Fixation
发起方: Smith & Nephew, Inc.
入组人数: 149
试验地点: 4
主要终点: Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention
状态: 已完成
最后更新: 去年

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Post-market clinical follow-up (PMCF) on the PEEK Suture Anchors in the hip.

注册库

clinicaltrials.gov

开始日期

2019年5月10日

结束日期

2019年9月10日

最后更新

去年

研究类型

Observational

性别

All

研究者

发起方

Smith & Nephew, Inc.

责任方

Sponsor

入排标准

入选标准

•Subjects who have undergone hip joint repair using the study devices.
•Subjects aged 18 years and older at the time of surgery.
•Subjects who had a visit to their provider between 3 and 15 months postoperative.

排除标准

•Subjects who are \< 12 months post-operative.
•Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery
•Subject had off-label use of the PEEK suture anchor during surgery.

结局指标

主要结局

Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention

时间窗: 6 months

Clinical success was defined as hip repairs without signs of device failure and/or re-intervention as assessed by the surgeon (Yes/No). Specifically, clinical success was achieved with "Yes" responses on the following 3 main criteria: * no inflammatory or allergic response * no device-related adverse event (AE) * no device deficiencies (DDs) leading to revision surgery (reintervention) on the index hip

次要结局

Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention(12 months)
Visual Analog Scale (VAS) - Pain(6 and 12 months)
Count of Participants With Range of Motion (ROM) Full Functional Arc(6 months and 12 months)
Range of Motion (ROM)(6 and 12 months)