Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 14
- 主要终点
- Number of Participants Not Requiring Removal or Reoperation of the Implant
研究概览
简要总结
The purpose of this study is to collect postmarket data in subjects who receive surgical treatment of a full-thickness rotator cuff tear (of at least 1.5 cm) with the BioWick™ SureLock™ implant. Both performance and safety data will be collected.
详细描述
Study Title Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs
Sponsor Cayenne Medical, Inc., a Zimmer Biomet company
Study Design The study is a prospective, non-randomized, open-label, single-arm study that includes both preoperative assessments and follow-up assessments at 3 months, 6 months, and 12 months.
Clinical Phase Postmarket
Number of Sites Up to ten sites in the U.S.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinical diagnosis of rotator cuff tear which is greater than or equal to 1.5 cm and less than or equal to 4.0 cm full thickness of either the supraspinatus or infraspinatus determined by MRI which has not been previously repaired;
- •Goutallier Stage 2 or less;
- •Patte Stage II (mid humeral head retraction);
- •Tear(s) confirmed intra-operatively by calibrated probe, tears measured in both anterior-posterior and medial-lateral planes;
- •Subject is skeletally mature at the surgical site;
- •Subject is able to read and understand the ICF and has voluntarily provided written informed consent.
排除标准
- •Clinical diagnosis of a rotator cuff tear of the subscapularis that requires repair (not including debridement);
- •Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow postoperative care or study instructions;
- •If female, subject is pregnant;
- •Presence of local or systemic infection;
- •Suprascapular nerve compression requiring release or documented by EMG-NCV;
- •Substance abuse, including tobacco, alcohol, or illicit drugs which, in the investigator's judgment, could impair healing or influence study compliance;
- •Foreign body sensitivity. If material sensitivity is suspected, testing should be completed prior to device implantation;
- •Insufficient blood supply or previous infection which may hinder the healing process;
- •Subject conditions including: insufficient quantity or quality of bone or soft tissue, or immature bone where the device may impact or disrupt the growth plate;
- •Subject is a prisoner or member of another vulnerable population;
- •Cortisone injection within 6 weeks prior to surgical treatment;
- •Use of immune suppressants or chemotherapeutic medications within the last 12 months;
- •Use of systemic corticosteroids at any daily dose for more than 1 month within the last 12 months.
结局指标
主要结局
Number of Participants Not Requiring Removal or Reoperation of the Implant
时间窗: 12 months
The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).
次要结局
- Number of Participants Not Requiring Removal or Reoperation of the Implant(3 months, 6 months)
- American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score(Preoperative, 3 months, 6 months, 1 year)
- Visual Analogue Scale (VAS) Pain Score(Preoperative, 3 months, 6 months, 1 year)
- The Veterans RAND 12 (VR-12) Item Health Survey Physical Score(Preoperative, 3 months, 6 months, 1 year)
- The Veterans RAND 12 (VR-12) Item Health Survey Mental Score(Preoperative, 3 months, 6 months, 1 year)
- Range of Motion (ROM) - Active Forward Elevation(Preoperative, 3 months, 6 months, 1 year)
- Device Safety(1 year)