A Randomized, Post-market Study Evaluating Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- The primary outcome measure is healing evaluation in MRI
研究概览
简要总结
The purpose of this study is to compare postoperative healing of large and massive rotator cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired with or without dermal allograft augmentation (DAA).
详细描述
The primary objective is to evaluate postoperative healing of rotator cuff repair with and without DAA.
Primary: The primary outcome measure is healing evaluation in MRI . MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification)
Secondary: The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems, including:
American Shoulder and Elbow Surgeons Score (ASES)
Single Assessment Numeric Evaluation score (SANE)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is between the ages of 30 and 75 years.
- •Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
- •Two complete RCTs or tear size equal to or greater than 3 cm in either the anterior-posterior or medial-lateral dimension
- •Primary rotator cuff repair
- •Stage II fatty infiltration or higher of the supraspinatus or infraspinatus muscle based on preoperative MRI
- •Subject has a dual x-ray absorptiometry (DXA) or anterior posterior x-ray view of the target shoulder
排除标准
- •The Subject is unable or unwilling to sign the patient informed consent, approved by the Institutional Review Board.
- •The subject objects to the use of allograft
- •Stage I or lower fatty infiltration of the supraspinatus AND infraspinatus muscle
- •Complete full-thickness subscapularis tears of greater than the superior one third of the tendon (Lafosse grade 3 and above)
- •Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
- •Recurrent shoulder instability
- •Corticosteroid injection in the operative shoulder within one month of surgery
- •Revision rotator cuff repair
- •Subject preoperative MRI obtained more than 12 months prior to surgery
- •Pregnant or planning to become pregnant during the study period
- •Workman's compensation case
- •Subject has conditions or circumstances that would interfere with study requirements.
- •Intraoperative exclusion criteria:
- •Partial rotator cuff repairs
- •Lafosse grade 3 or higher subscapularis tears
结局指标
主要结局
The primary outcome measure is healing evaluation in MRI
时间窗: 26 Weeks
MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification) MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification)
次要结局
- The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems(Preop, 26 Weeks, 1 Year, 2 Year)
- Single Assessment Numeric Evaluation score (SANE)(Preop, 26 Weeks, 1 Year, 2 Year)
- Veterans RAND Health Survey (VR-12)(Preop, 26 Weeks, 1 Year, 2 Year)
- Visual Analog Scale (VAS) for pain(Preop, two-week, six week, 26 Weeks, 1 Year, 2 Year)