A Prospective, Randomized Study Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty Using the ReUnion System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Shoulder Abduction Strength
研究概览
简要总结
The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere with either a +2 mm or a +6 mm offset.
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
- 50 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 non-pregnant female subjects ages 50 - 90 at the time of surgery
- •Subjects requiring a primary reverse total shoulder arthroplasty
- •Subjects with the diagnosis of cuff-tear arthropathy (CTA), massive irreparable rotator cuff tear (MRCT) or osteoarthritis (OA) with marked posterior subluxation or bone loss
排除标准
- •Inability to comply with follow-up requirements
- •Subjects with inflammatory arthritis
- •Subjects with proximal humerus fractures
- •Subjects with sequels of trauma
- •Subjects that are immunologically compromised
- •Subjects with an active or suspected latent infection in or about the shoulder
- •Need to add a tendon transfer
- •Need for structural humeral bone graft
- •Pregnant subjects
研究组 & 干预措施
Large-Diameter Glenosphere +2 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset
干预措施: ReUnion System with a Large-Diameter Glenosphere +2 mm offset (Device)
Small-Diameter Glenosphere +2 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset
干预措施: ReUnion System with a Small-Diameter Glenosphere +2 mm offset (Device)
Large-Diameter Glenosphere +6 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset
干预措施: ReUnion System with a Large-Diameter Glenosphere +6 mm offset (Device)
Small-Diameter Glenosphere +6 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset
干预措施: ReUnion System with a Small-Diameter Glenosphere +6 mm offset (Device)
结局指标
主要结局
Shoulder Abduction Strength
时间窗: one year
Shoulder abduction strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Active Forward Elevation of the Shoulder
时间窗: One year
Degrees of movement the participant is able to independently lift arm upward to the ceiling, while keeping elbow straight. Normal movement for forward elevation is 180 degrees.
Active External Rotation of the Shoulder
时间窗: One year
Degrees of movement the participant is able to independently rotate arm up, while keeping arm at 0 degrees of abduction. Normal movement for external rotation is 90 degrees.
Shoulder External Rotation Strength
时间窗: One year
Shoulder external rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Shoulder Internal Rotation Strength
时间窗: One year
Shoulder internal rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
次要结局
- Patient Satisfaction(One year)
- Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire(One year)
- Shoulder Pain(One year)
- American Shoulder and Elbow Surgeons (ASES) Questionnaire(One year)
- Oxford Shoulder Score (OSS) Questionnaire(1 year)
研究者
Mark E. Morrey, M.D.
Principal Investigator
Mayo Clinic