Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair
赞助:
Smith & Nephew Orthopaedics AG
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 1, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | September 30, 2018 | ||
| 预计主要完成日期 | September 30, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Clinical success rate[ Time Frame: 6 month post-surgery ] Subjects without signs of failure and/or re-intervention |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair | ||
| 正式标题 ICMJE | Prospective, Multicenter, Post-Market 1 Year Clinical Follow-up Study to Evaluate Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair | ||
| 简要概况 | The scientific justification is to fulfill post-market clinical requirements in order to support re-certification of the CE-Mark for this marketed product and to look into safety and efficacy. |
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| 详细说明 | Shoulder: The superior labrum (fibrous cartilage) and biceps anchor improve joint stability by acting like a secondary stabilizer to the shoulder. Labral injuries are usually associated with anterior shoulder dislocation. When conservative treatment fails, such as physical therapy, strengthening programs, anti-inflammatories and activity modification to improve symptoms, surgical intervention may be required. Surgical treatments can include simple debridement (the medical removal of dead damaged or infected tissue), stabilization of the biceps-labrum complex through repair, or biceps tenodesis where the end of a tendon is joined surgically to the bone. Outcomes of SLAP (superior labral tear from anterior to posterior) repairs have been reported good throughout the literature, with reported success rates ranging from 71-97%. Hip: The labrum of the hip is a fibrocartilaginous tissue that connects to the bone edge of the acetabulum (the socket of the hip bone), and deepens the acetabular socket while extending coverage of the femoral head; it also aids in hip stabilization. The goal of surgical intervention is to restore normal hip mechanics and treat existing damage. In an epidemiology study published in 2017, labral pathology was the most common diagnosis at 82% of the population. Of the 1,124 tears reported, 75.3% were repaired, 13.7% were reconstructed and 7.2% were debrided. | ||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
80 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 30, 2020 | ||
| 预计主要完成日期 | September 30, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Subject has consented to participate in the study by signing the EC-approved informed consent form - Subject condition meets proposed indication to SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchor - Subject requiring shoulder or hip arthroscopic labral repair surgery from physical findings, subject symptoms and radiographic finding Hip subjects - FAI (Femoroacetabular Impingement) Shoulder subjects - Subject with a history of recurrent dislocation/subluxation of the shoulder Exclusion Criteria: - Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1 (pre-operative) - Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures - Contraindications or hypersensitivity to the use of the SUTUREFIX ULTRA and/or SUTUREFIX CURVED Suture Anchor, or their components (e.g. silicone, polyester). Where material sensitivity is suspected, appropriate tests should be performed and sensitivity ruled out prior to implantation - Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation - Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture - Comminuted bone surface, which would compromise secure anchor fixation Hip subjects Dysplasia latera/central less than 20° Shoulder subjects - Glenoid and/or humeral bone loss considered excessive by the treating orthopaedic surgeon | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Denmark|Finland|Spain|United Kingdom | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Smith & Nephew Orthopaedics AG | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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