Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Subscapularis repair integrity assessed by lift-off test using dynamometry.
研究概览
简要总结
The purpose of this study is to evaluate whether augmentation of subscapularis repair with the Regeneten implant after anatomic total shoulder arthroplasty (TSA) can improve rates of subscapularis healing and improve clinical outcomes.
详细描述
Subscapularis management is an area of controversy in the literature for total shoulder arthroplasty (TSA). Regeneten has been suggested as a bioinductive implant to aid in rotator cuff healing. We hypothesize that applying this technology could aid in obtaining higher rates of subscapularis healing for TSA when utilizing SP or ST, which in turn could lead to improved outcomes.The 50 randomized subjects will be randomized at a 1:1 ratio into the standard subscapularis repair group or the standard repair with Regeneten augmentation group. Subjects will be blinded to their treatment assignment until they complete all study visits. Upon withdraw from the study, termination from the study, or new or recurrent symptoms requiring a subsequent surgical procedure, the blinded assignment will be revealed to the subject. Subjects will be assessed pre-operatively and return post-operatively at Week 2, Weeks 6, Month 3, Month 6, and Year 1. The primary outcome will evaluate subscapularis repair integrity and healing at one year post-op.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients healthy enough to undergo primary anatomic TSA
- •Being treated with subscapularis tenotomy or subscapularis peel.
- •Age 50 or above
- •Intact rotator cuff including subscapularis as determined by preoperative examination and imaging (typically preoperative CT, MRI if indicated or available).
排除标准
- •Revision arthroplasty
- •Reverse arthroplasty
- •Requiring a lesser tuberosity osteotomy
- •Intraoperative identification of rotator cuff tear requiring repair
- •Object to using cow derived material
- •Prior index shoulder surgery requiring treatment to the subscapularis
结局指标
主要结局
Subscapularis repair integrity assessed by lift-off test using dynamometry.
时间窗: 12 months post-op
Pounds (lbs) of force that the subject can produce during the lift off test will be recorded.
次要结局
- Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)(6 months)
- Abduction active range of motion as assessed by treating physician(12 months)
- Patient reported clinical outcome scores- American Shoulder and Elbow Surgeon Evaluation (ASES)(12 months)
- Patient reported clinical outcome scores- Simple shoulder test (SST)(12 months)
- External rotation active range of motion as assessed by treating physician(12 months)
- Forward elevation active range of motion as assessed by treating physician(12 months)
- Patient reported clinical outcome scores- Simple shoulder value (SST)(12 months)
- Internal rotation active range of motion as assessed by treating physician(12 months)
- Patient reported clinical outcome scores- Visual Analog Scale (VAS)(12 months)
研究者
Gregory Cvetanovich
Assistant Professor
Ohio State University