Subscapularis Repair in Reverse Shoulder Arthroplasty: A Multi-Center Randomized Single Blinded Superiority Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Change in Internal Rotation
研究概览
简要总结
The subscapularis is part of the rotator cuff and is release as part of a reverse shoulder replacement. The decision to repair this tendon is controversial. This research is being done to help determine if rotator cuff repair improves or hinders shoulder replacement. A worrisome but rare complication after shoulder replacement is dislocation. Rotator cuff repair may help reduce this risk. The repair may hinder some of the range of motion afterwards or could help with internal rotation strength. There is a chance that the repair doesn't matter at all. The goal of this study is to delineate outcomes after reverse shoulder arthroplasty with the respect to management of the subscapularis tendon. Further information about rotator cuff repair after reverse shoulder replacement can help define complications, potentially decrease OR time, and improve functional outcomes. A total of 148 patients will be enrolled and the duration of the study will be 5 years. All patients will be required to follow-up at 2¬-week, 6-week, 3-month, 6-month, 1-year, and 2-year post-operative marks. Any time information is collected for a study there is a small risk of breach of confidentiality. There are no monetary costs or payments associated with this study. You may or may not benefit by taking part in this study. There is no guarantee that you will receive direct benefit from your participation in this study. To be clear, participation in this study is completely voluntary.
详细描述
You're going to undergo a procedure called a reverse shoulder replacement and I'm sure Dr. Gilotra already went over the procedure with you but I will again briefly. Before the hardware is put in, there is a tendon in your shoulder that has to be "released". It's released because the doctor has to move it out of the way to get to your shoulder joint. Now when the hardware has been implanted and the surgery is complete, the doctor now has two options. He can decide to repair this tendon or not. The thing is due to the hardware that is implanted, your shoulder doesn't really need this tendon anymore to help it move. So, there are some doctors in the country who choose to repair the tendon and there are some doctors who choose to just let it be. Patients have done great with either or.
We are performing this nationwide study to see if one option (between repairing this tendon or leaving it) is slightly better than the other. There is a chance that repairing the tendon can decrease the risk of dislocations in the future and also help you move your arm better. There is a chance that this repair doesn't matter at all. If we figure out whether to repair or not to repair this tendon, we will be able to better define complications, potentially decrease surgery time, and improve how well patients perform daily activities.
We randomize you to the repair on don't repair group, almost like flipping a coin. With me, you'll be answering simple questions that will track your functionality over time.
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
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 95 years old
- •Undergoing reverse shoulder arthroplasty for any indication including revision surgery
排除标准
- •Irreparable Subscapularis Tendon
- •a. Reparability of Subscapularis will be determined based on MRI or CT scan obtained preoperatively and confirmed intraoperatively. Tendons must be intact with less than Grade I or II Fatty Infiltration as determined by the Goutallier classification.
- •Any history of proximal humerus fracture
- •Any revision with proximal humerus bone loss
研究组 & 干预措施
Subscap Tenotomy
The subscapularis tendon is not repaired.
干预措施: Subscap Tenotomy (Procedure)
Subscap Repair
The subscapularis tendon is repaired.
干预措施: Subscap Repair (Procedure)
结局指标
主要结局
Change in Internal Rotation
时间窗: Pre-op and post-op Months 3,6,12,24
Internal rotation behind the back
Change in BOSS Scores
时间窗: Pre-op and post-op Months 3,6,12,24
Change in Baltimore Orthopaedic Subscapularis Score (BOSS) over 2 years. The score asks enrolled patients a series of questions. The answer choices are the following: No difficulty, mild difficulty, severe difficulty, unable to perform.
次要结局
- Change in ASES score(Pre-op and post-op Months 3,6,12,24)
研究者
Mohit N. Gilotra
Associate Professor
University of Maryland, Baltimore