Clinical Outcomes of Patients 60 Years of Age and Older: Reverse Total Shoulder Arthroplasty Versus Rotator Cuff Repair Involving Three Tendon Tears
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- American Shoulder Elbow Surgeons
研究概览
简要总结
To compare the one year outcomes between 60 year old patients with a three tendon tear treated as part of their standard of care with either a reverse total shoulder arthroplasty or rotator cuff repair surgery.
详细描述
A retrospective record review will be completed to identify eligible subjects who had either a reverse total shoulder arthroplasty or rotator cuff repair to treat their three tendon tear. Medical record abstraction of standard of care will be completed among the reverse total shoulder arthroplasty cohort. Rotator cuff repair subjects will be contacted with a study invitation and scheduled for a single study visit to collect three patient reported outcomes, assess range of motion and complete a ten-minute magnetic resonance imaging exam following signed consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 60 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 years of age or more at time of surgery
- •One year post-reverse total shoulder arthroplasty or one year post-rotator cuff repair involving all three tendons (infraspinatus, supraspinatus, subscapularis)
- •Surgery completed by Dr. Tyler Brolin or Dr. Thomas Throckmorton
排除标准
- •Less than 60 years of age at time of surgery
- •Less than one year post-reverse total shoulder arthroplasty or post-rotator cuff repair
- •Procedure completed by another provider than Dr. Brolin or Dr. Throckmorton
- •Worker's compensation
- •Fewer than three tendon tear
研究组 & 干预措施
Reverse Total Shoulder Arthroplasty
Retrospective record review and data abstraction of standard of care data preoperative and at least one year postoperative to include patient reported outcomes and range of motion measurements.
干预措施: Reverse Total Shoulder Arthroplasty (Procedure)
Rotator Cuff Repair
Retrospective record review and data abstraction of standard of care data preoperative to include patient reported outcomes and range of motion measurements. Study invitation will be extended to subjects for completion of a single study visit to collect three patient reported outcomes, range of motion and a ten minute magnetic resonance imaging exam.
干预措施: Rotator Cuff Repair (Procedure)
结局指标
主要结局
American Shoulder Elbow Surgeons
时间窗: one year after surgery
numeric scale to quantify shoulder function from zero (worst) to one hundred (best)
Single Assessment Numeric Evaluation
时间窗: one year after surgery
Satisfaction with Shoulder
Visual Analog Scale
时间窗: one year after surgery
numeric scale to quantify shoulder pain from zero (no pain) to ten (worst pain)
American Shoulder Elbow Surgeons
时间窗: 90 days before surgery to day of surgery
numeric scale to quantify shoulder function from zero (worst) to one hundred (best)
Visual Analog Scale
时间窗: 90 days before surgery to day of surgery
numeric scale to quantify shoulder pain from zero (no pain) to ten (worst pain)
Single Assessment Numeric Evaluation
时间窗: 90 days before surgery to day of surgery
Satisfaction with Shoulder
次要结局
- Revision rate(one year after surgery)
- Sugaya(one year after surgery)
- Range of motion(one year after surgery)
- Range of motion(90 day to surgery)