ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, a Single Center Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan
研究概览
简要总结
The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.
详细描述
The objectives of the study are to document that ROSA Knee System can provide intraoperative planning adjustment based on feedbacks obtained by laxity as well as gaps to locally preferred surgeon's operative philosophy. This will also provide accuracy, intraoperative soft tissue release as well as patient outcome on locally preferred surgical technique.
The primary endpoint is defined as the mean absolute difference between X-Atlas image-based pre-op plan & intra-op final plan.
The secondary endpoints include Kinematic Analysis, EuroQol 5 dimensions (EQ-5D), Rehabilitation record, Knee Society Score (KSS) 2011, image assessment and Safety up to 2 years postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years and over
- •Skeletally matured
- •Decision to have Total Knee Arthroplasty with ROSA Knee System being made independently and prior to recruitment into study
- •Willing and able to complete scheduled follow-up evaluations as described in the study protocol
- •Has participated in the informed consent process and is willing and able to sign an Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form
排除标准
- •Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft
- •Is septic, has an active infection or has osteomyelitis at the affected joint
- •Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
- •Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- •Is known to be pregnant
- •Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
- •Has a known sensitivity or allergy to one or more of the implanted materials
结局指标
主要结局
The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan
时间窗: Immediate post-operative
The mean absolute difference between X-Atlas image-based pre-op plan and intra-op final plan in order to demonstrate the ability of the system to allow for intra-operative adjustments
次要结局
- Kinematic analysis(Postoperative 12 months or 24 months)
- QOL(Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months)
- Image review (CT/Radiograph)(Preoperative, Discharge, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months)
- Pain, range of knee motion and functional performance(Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months)
- Rehabilitation record(Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months)