NCT00719771已完成不适用
A Multi-center Clinical Study of the Global® AP™ Shoulder in Total Shoulder Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 8
- 主要终点
- Constant Shoulder Score
研究概览
简要总结
This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations.
详细描述
The purpose of the study is to determine the difference between pre-operative and post-operative levels of patient satisfaction, shoulder function, radiographic alignment, shoulder pain and patient satisfaction in patients receiving a Global® AP™ shoulder prosthesis for glenohumeral arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients selected for inclusion will present for primary shoulder arthroplasty with a diagnosis of osteoarthritis and will consent to participate.
排除标准
- •Are under 18 years of age or over 70
- •Diagnosis of AVN, Inflammatory Arthritis, Fracture or Malunion.
- •Have a hemi-arthroplasty
- •Have destruction of the proximal humerus that precludes rigid fixation of the humeral component
- •Have arthritis with insufficient cuff tissue
- •Have had a failed rotator cuff surgery
- •Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified
- •Have evidence of active infection
- •Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint) - Have a known active metastatic or neoplastic disease
- •Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol
- •Are skeletally immature.
- •Have a known allergic reaction to implant metals, polyethylene or a tissue reaction to corrosion or wear products
- •Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible
- •Are currently participating in another clinical study
- •Are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
- •Are currently involved in any personal injury litigation, medical legal or worker's compensation claims.
结局指标
主要结局
Constant Shoulder Score
时间窗: Pre-op, 6, 12, 24 months
次要结局
- SF-12(Pre-op, 6,12, 24 months)
- Penn/ASES(Pre-Op, 6, 12, and 24 months)
- Radiographic Data(Pre-Op, 6 weeks, 6, 12, and 24 months)
- Quality of Life Survey(6 weeks)
研究者
研究点 (8)
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