ACTRN12620001271998尚未招募未知
A multi-centre, single-arm, prospective, pre-market, pivotal study on robotic instrumentation (ROSA® Partial Knee System) implant accuracy in patients undergoing medial unicompartmental knee arthroplasty
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 72
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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Body mass index greater than or equal to 40 kg/m2
- •2) Patient qualifies for primary UKA for isolated medial compartment osteoarthritis based on investigator’s clinical judgement and has an intact ACL.
- •3) Independent of study participation, patient is a candidate and meets the indications and contraindications for UKA of the medial compartment with the Persona® partial knee system.
排除标准
- •1) Infection, Sepsis, Osteomyelitis
- •2) Inflammatory or Post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis.
- •3) Prior ACL repair.
- •4) Varus/Valgus deformity greater than 15 degrees.
- •5) Orthopaedic procedure or pain management study of any joint within the last or next 6 months
研究者
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