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 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- arthritis
- 发起方
- Zimmer Biomet Nederland bv
- 入组人数
- 30
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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.);
结局指标
主要结局
未指定
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