Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluate arthritis on shoulder x-ray
研究概览
简要总结
The primary purpose of this research is to compare the images obtained by ultrasound between a standard repair of the subscapularis tissue and after repair with a Biobrace. The secondary purpose is to determine if there are any clinical differences.
详细描述
The investigators would like to learn if subscapularis repair augmentation with the Biobrace in total shoulder arthroplasty (reverse and anatomic) will result in sonographic and/or clinical improvements. This will allow for improvements in technique and better outcomes for patients going forward.
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)
盲法说明
The physician performing the ultrasound evaluation will be blinded to which treatment arm.
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
- •Total Shoulder Arthroplasty
排除标准
- •Vulnerable population
研究组 & 干预措施
BioBrace Augmentation
During the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to the BioBrace, patient will receive BioBrace augmentation of the standard subscapularis repair.
干预措施: BioBrace Augmentation (Device)
Standard Repair with Sutures
During the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to standard repair, patient will receive the standard repair with sutures.
干预措施: Standard Repair with Sutures (Procedure)
结局指标
主要结局
Evaluate arthritis on shoulder x-ray
时间窗: Surgery
Amount of arthritis or wear patterns on shoulder x-Ray
Difference in thickness of the subscapularis tissue on ultrasound
时间窗: 3 months, 1 years after surgery
Thickness of subscapularis tissue on ultrasound
Difference in continuity of subscapularis tissue on ultrasound
时间窗: 6 weeks, 6 months after surgery
Continuity of subscapularis tissue on ultrasound
Difference in signs of loosening or wear patterns in shoulder X-Ray
时间窗: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Signs of loosening or wear patterns on shoulder x-ray
次要结局
- Shoulder examination for the difference in Active Range of Motion(3 months, 6 months, 1 year, 2 years after surgery)
- American Shoulder & Elbow Surgeons Score (ASES) score(2 weeks, 3 months, 6 months, 1 year, 2 years after surgery)
- Shoulder examination for the difference in Passive Range of Motion(2 weeks, 3 months, 6 months, 1 year, 2 years after surgery)
研究者
Michael T. Freehill
Associate Professor of Orthopaedic Surgery
Stanford University