ACTRN12618000990224已完成未知
A clinical evaluation of ROSA Knee 1.0 Robotic Total Knee Application used in primary total knee arthroplasty - a pilot study to evaluate the ROSA Knee System applications and performance intra-operatively.
Zimmer Biomet Pty Ltd0 个研究点目标入组 64 人开始时间: 2018年6月13日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 64
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 o limit（—）
- 性别
- All
入选标准
- •Patient qualifies for a primary total knee arthroplasty based on the investigator’s clinical judgement
- •Independent of study participation, patient is a candidate for commercially available Persona Total Knee or Vanguard Total Knee or NexGen Total Knee arthroplasty
排除标准
- •Patient has active, local infection or previous intra-articular infection in the affected joint
- •Insufficient bone stock on femoral or tibial surfaces
- •Neuropathic arthroplasty
- •Osteomalacia or any metabolic disorder which may impair bone formation
- •Severe instability secondary to the absence of collateral ligament integrity
- •Rheumatoid arthritis accompanied by an ulcer of the skin or history of recurrent breakdown of the skin
研究者
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