Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in bone-to-bone contact between tuberosity and acromion
研究概览
简要总结
The purpose of this study is to examine bone-to-bone contact between the tuberosity as compared to a subacromial balloon spacer procedure. Using biplanar fluoroscopy to determine the three-dimensional (3D) motion of the shoulder compared pre-procedure to post-procedure, the investigators will be able to assess 1) the bone-to-bone contact of the tuberosity and acromion in the setting of a massive posterior superior rotator cuff tear 2) if the placement of a dermal allograft over the tuberosity does indeed decrease bone contact and 3) if the placement of a subacromial balloon spacer decreases bone-to-bone contact. Doing so will allow assessment of the relative contribution of the implant for arm elevation versus potential compensatory motion of increased scapulothoracic motion. The investigators will also be able to correlate this to patient-reported outcomes of pain and shoulder function.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus.
- •No involvement of the subscapularis.
- •Centered humeral head on X-ray examination.
- •Primary complaint of pain.
- •History of prior surgery, including failed rotator cuff repair.
排除标准
- •Involvement of the subscapularis.
- •Acromiohumeral distance less than 7 mm on upright anterior-posterior (AP) radiograph.
- •Rotator cuff deemed repairable at the time of surgery.
- •Patients younger than 65 years due to FDA clearance of the subacromial balloon spacer only for patients over 65
研究组 & 干预措施
biologic tuberoplasty group
massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus, no involvement of the subscapularis, centered humeral head on X-Ray examination, and a primary complaint of pain, randomized to biologic tuberoplasty surgery.
干预措施: biologic tuberoplasty (Procedure)
subacromial balloon spacer group
massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus, no involvement of the subscapularis, centered humeral head on X-Ray examination, and a primary complaint of pain, randomized to subacromial balloon spacer.
干预措施: subacromial balloon spacer (Procedure)
结局指标
主要结局
change in bone-to-bone contact between tuberosity and acromion
时间窗: presurgery, 6 months postop, 12 months postop
degree of change in bone-to-bone contact between tuberosity and acromion as assessed using biplanar fluoroscopy
shoulder range of motion
时间窗: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
quantitative measurement in degrees with a goniometer of shoulder motion in forward elevation, abduction, external rotation, and internal rotation
single assessment numerical evaluation (SANE) of the shoulder
时间窗: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
a validated tool providing a numerical score from 0-100 that assess shoulder function as subjectively reported by the subject. A higher score indicates superior shoulder function.
American shoulder and elbow surgeons (ASES) score
时间窗: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
a validated survey with possible scores from 0-100 that assesses shoulder function as reported by the subject. A higher score indicates superior shoulder function.
次要结局
未报告次要终点