NL-OMON52310招募中不适用
Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the Avenir Complete* Femoral Stem (Implants and Instrumentation) - Avenir Complete PMCF
Zimmer Biomet Nederland bv0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patient is at least 20 years old or older and skeletally mature.
- •- Patient is capable of understanding the surgeon*s explanations and following
- •his instructions, able and willing to participate in the follow-up program and
- •who gave consent to take part in the study;
- •- Patient qualifies for total hip arthroplasty based on physical exam and
- •medical history including at least one of the following:
- •o Advanced wear of the joint due to degenerative, post-traumatic or rheumatic
- •o Failed previous hip surgery including:
- •* joint reconstruction (osteotomy)
- •* Arthrodesis
- •* Hemi-arthroplasty or total hip replacement (THR);
- •o Acute traumatic fracture of the femoral head or neck;
- •o Avascular necrosis of the femoral head.
排除标准
- •- Acute, chronic, local, or systemic infections;
- •- Severe muscular, neural, or vascular diseases that endanger the limbs
- •- Lack of bony structures proximal or distal to the joint, so that good
- •anchorage of the implant is unlikely or impossible;
- •- Total or partial absence of the muscular or ligamentous apparatus;
- •- Any concomitant diseases that can jeopardize the functioning and the success
- •of the implant;
- •- Allergy to the implanted material, especially to metal (e.g. cobalt,
- •chromium, etc.);
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