NCT02052466已完成不适用
Prediction of Development of Scapular Notching Based on Glenosphere Positioning, Scapular Morphology, and Simulated Impingement-free Motion Using Three-dimensional Computed Tomography Analysis
Eric Ricchetti1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Actual Versus Predicted Scapular Notching
研究概览
简要总结
The hypothesis is that computer simulated bony impingement of the bone surrounding the spherical glenoid implant (the glenosphere) along the scapular neck on three-dimensional (3-D) computed tomography (CT) imaging analysis is predictive of the location of clinical scapular notching that develops following reverse total shoulder arthroplasty (TSA).
详细描述
The Specific Aims are:
- Determine the relationship between lateral glenoid offset and the development of scapular notching following reverse TSA
- Determine the ability of 3-D preoperative planning tools to define areas of scapular bony impingement on kinematic simulated shoulder range of motion that predict the development of scapular notching
- Compare the precision and accuracy of plain radiographs (2-D) versus CT (3-D) for measurement of scapular notching and postoperative implant position following reverse TSA (2-D versus 3-D)
- Determine the implant and anatomic factors that best correlate with clinical outcome following reverse TSA by retrospective analysis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and a minimum of two years out from surgery
排除标准
- •All patients having undergone reverse TSA at the Cleveland Clinic with no preoperative CT or a low quality preoperative CT of the operative shoulder and/or less than two years from surgery
结局指标
主要结局
Actual Versus Predicted Scapular Notching
时间窗: At least 24 months after reverse TSA
At minimum 2 year follow-up, compare presence of scapular notching as assessed by 2D x-ray and 3D CT imaging with predicted scapular notching as assessed by 3D computer modeling using video motion analysis of subject range of motion.
次要结局
- Shoulder Strength - Internal Rotation(At least 24 months after TSA)
- Active Shoulder Range of Motion - Flexion(At least 24 months after reverse TSA)
- Active Shoulder Range of Motion - External Rotation(At least 24 months after reverse TSA)
- Passive Shoulder Range of Motion - Abduction(At least 24 months after reverse TSA)
- Passive Shoulder Range of Motion - External Rotation(At least 24 months after reverse TSA)
- Active Shoulder Range of Motion - Abduction(At least 24 months after reverse TSA)
- Passive Shoulder Range of Motion - Flexion(At least 24 months after reverse TSA)
- Shoulder Strength - Abduction(At least 24 months after TSA)
- Shoulder Strength - External Rotation(At least 24 months after TSA)
- Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score)(At least 24 months after reverse TSA)
- Shoulder Strength - Flexion(At least 24 months after TSA)
研究者
Eric Ricchetti
Staff, Orthopaedic Surgery
The Cleveland Clinic
研究点 (1)
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