ACTRN12622000504718招募中未知
A Clinical Investigation to evaluate safety and performance of APEX KNEE ECiMa Patella and Tibial Insert components in primary Total Knee Arthroplasty in patients with knee osteoarthritis
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 300
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •1. Minimum 18 years of age, maximum age limit 80
- •2. Be capable of understanding the study requirements and of
- •providing informed consent
- •3. Be eligible for a primary total knee replacement with APEX Knee
- •based on history, physical examination and radiological
- •evaluation.
- •4. Agree to attend the research centre for the required postoperative
- •assessments and radiological evaluation.
排除标准
- •Exclusion Criteria:
- •1. Women who are pregnant or breast feeding or plan to become
- •pregnant during the course of the study.
- •2. Not willing or unable to return for required follow-up visits or clear
- •demonstration of likely poor compliance.
- •3. Any medical condition including current infections that in the
- •judgement of the investigator would prohibit the patient from
- •participating in the study
- •4. Psychiatric or mental disorders, alcohol abuse or other substance
- •abuse, which in the opinion of the investigator would inhibit
- •compliance with routine surgical follow-up.
- •5. The individual has a neuromuscular or neurosensory deficiency
- •that limits the ability to evaluate the safety and effectiveness of
- •the device.
- •6. Previous patellectomy
- •7. Previous proximal tibial or distal femoral osteotomy.
- •8. Extra-articular deformity
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