Randomized Clinical Trial Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Radiographic loosening
研究概览
简要总结
Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects willing to sign the informed consent
- •Male and female subjects ages 18 - 90 at the time of surgery
- •Subjects indicated for an anatomic total shoulder arthroplasty (including primary glenohumeral osteoarthritis, avascular necrosis, and inflammatory arthritis)
排除标准
- •Inability to comply with follow-up requirements
- •Known or presumed substantial rotator cuff disorders
- •Subjects with an active or suspected latent infection in or about the shoulder
- •Subjects with instability (surgically or non-surgically addressed)
- •Subjects presenting with posttraumatic avascular necrosis
- •Need for glenoid bone grafting
- •Pregnant subjects
研究组 & 干预措施
Pegged through SP
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through a Subscapularis Peel (SP) manipulation.
干预措施: ReUnion TSA, pegged design (Procedure)
Pegged through ST
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through subscapularis tenotomy (ST) manipulation.
干预措施: ReUnion TSA, pegged design (Procedure)
Keeled through SP
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through a Subscapularis Peel (SP) manipulation.
干预措施: ReUnion TSA, keeled design (Procedure)
Keeled through ST
Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through subscapularis tenotomy (ST) manipulation.
干预措施: ReUnion TSA, keeled design (Procedure)
结局指标
主要结局
Radiographic loosening
时间窗: 5 years
"glenoid at risk" proportion
Function of Subscapularis muscle as measured by belly-press test
时间窗: 5 years
次要结局
未报告次要终点
研究者
Mark E. Morrey, M.D.
Principal Investigator
Mayo Clinic