NCT04982198已完成不适用
Robotic-assisted Versus Conventional Total Knee Arthroplasty: A Multicenter and Randomized Controlled Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Mechanical axis alignment
研究概览
简要总结
This is a multicenter, prospective and randomized controlled pre-market clinical Trial. Study subjects will be randomized into one of two operative groups: 1) TKA assisted with ROSA® Knee System; 2) TKA with conventional surgical instrumentation.
详细描述
The objective of this clinical trial is to measure the effectiveness and safety of the ROSA® Knee System in assisting surgeons with bone resections and implant positioning optimization through early clinical and radiographic outcomes compared with conventional surgical instrumentation in total knee arthroplasty (TKA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is age between 18 and 85 years old, inclusive;
- •Patient qualifies for a primary TKA based on the investigator's clinical judgement;
- •Patient is a candidate for commercially available Persona® Knee Joint Prosthese which is compatible with the ROSA® Knee System;
- •Patient is willing and able to provide written Informed Consent.
排除标准
- •Patient planning to receive bilateral TKA surgery within 3 months;
- •Patient who has undergone revision surgery for partial or total knee arthroplasty of the ipsilateral knee；
- •Bone tumor patient who has undergone bilateral TKA;
- •Stable, painless ipsilateral knee arthrodesis within a satisfactory function and position;
- •Patient who has received partial or total knee arthroplasty for the contralateral knee within 6 months prior to scheduled primary TKA;
- •Patient has active, local infection or previous intra-articular infection in the affected joint;
- •Insufficient bone stock on femoral or tibial surfaces;
- •Skeletal immaturity;
- •Osteomalacia or any metabolic disorder which may impair bone formation;
- •Patient has neurologic disorders (e.g. Stroke);
- •Patient hs diseases that could lead to prosthesis instability, failure of prosthesis fixation or postoperative complications (e.g. Arthrodesis, Scoliosis, Lumbar Stenosis)
- •Patient has a hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum);
- •Patient has hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation);
- •Patients with severe knee instability caused by incomplete collateral ligaments, cruciate ligaments, and posterolateral structural injury;
- •Rheumatoid arthritis accompanied by an ulcer of the skin or history of recurrent breakdown of the skin;
- •Patient has severe angular knee deformity of >20° varus or >20° valgus;
- •Patient has a known or suspected sensitivity or allergy to one or more of the implant materials;
- •Patient has other contraindications specified by the implant manufacturer;
- •Patient is pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent);
- •In the past 1 month participated in or is participating in clinical trials related to other drugs and medical devices;
- •Any other conditions that the investigator considers inappropriate for participation in this trial.
结局指标
主要结局
Mechanical axis alignment
时间窗: 6 weeks (±2 week) postoperatively
Deviation from neutral mechanical axis alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively.
次要结局
- Coronal Lower Limb Alignment(6 weeks (±2 week) postoperatively)
研究者
研究点 (1)
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