DRKS00003072招募中未知
A Randomized Multicenter Study Comparing the Effectiveness of Hemi- Versus Total Shoulder Arthroplasty in Patients With a Degenerative Joint Disease
AO Foundation0 个研究点目标入组 94 人开始时间: 2011年7月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 94
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age 18 years and older
- •Primary or secondary omarthrosis (eg, rheumatoid arthritis, avascular head necrosis)
- •Glenoid morphologic type A1, A2 or B1 according to Walch
- •Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation
- •Written informed consent
排除标准
- •Preoperative:
- •* Posttraumatic omarthrosis
- •* Biconcave aspect of glenoid (Walch type B2)
- •* Retroversion of glenoid more than 25° (Walch type C)
- •* Epoca Reko prosthesis
- •* Humerus fractures
- •* Patients with a severe systemic disease: class III-IV according to the American Society of Anaesthesiologists physical status classification (ASA)
- •* Substance abuse that would preclude reliable assessment
- •* Pregnancy
- •* Prisoners
- •* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- •Intraoperative:
- •* Full thickness tear of rotator cuff
- •* Indication for hemiarthroplasty only
- •* Indication for total arthroplasty only
- •* Intraoperative decision to use implants other than Epoca
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