Postoperative MRI Evaluation of the Integrity Bio-inductive Implant Augmentation of Rotator Cuff Tears of the Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- MRI Assessment of Adverse Events and Structural Integrity
研究概览
简要总结
The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are:
- How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS?
- What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant?
Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair.
详细描述
The aim of this prospective, non-randomized, open-label, single-arm study is to evaluate the safety and effectiveness of the newly FDA-cleared Integrity graft for various types of rotator cuff repairs. This study incorporates preoperative assessments as well as follow-up assessments at 3 months and 6 months postoperatively. The primary objective is to document the safety profile of the Integrity graft by monitoring device-related adverse events throughout the study duration. Additionally, the study aims to assess the post-market effectiveness of the Integrity implant using patient-reported outcome measures and establish normal or standard findings on MRI to aid surgeons in clinical decision-making.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rotator cuff tear (both partial and full thickness) treated with Integrity bio-inductive implant augmentation to the superior surface of partial rotator cuff tears or the superior aspect of rotator cuff repairs (both single or double row);
- •Subject can read and understand the ICF and has voluntarily provided written informed consent.
排除标准
- •Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow post- operative care or study instructions;
- •If patient is pregnant;
- •Subject conditions which may hinder the healing process;
- •Subject is a prisoner or member of another vulnerable population.
结局指标
主要结局
MRI Assessment of Adverse Events and Structural Integrity
时间窗: 3 and 6 months after index procedure
The primary endpoint of this study is the adverse events rate and structural failure rate of the rotator cuff repair, determined by MRI, at 3 months and 6 months following use of the Anika Integrity implant system.
次要结局
- Effectiveness Evaluation with PROMIS outcome tool(3 months after index procedure)
- Effectiveness Evaluation with SANE score(6 months after index procedure)
- Effectiveness Evaluation with PROMIS tool(6 months after index procedure)
- Effectiveness Evaluation with ASES rating scale(6 months after index procedure)
- Effectiveness Evaluation with SANE score(3 months after index procedure)
- Effectiveness Evaluation with ASES rating scale(3 months after index procedure)