Prospective, Randomized, Single-center Study Comparing the Stryker MAKO™ Robotic-Arm Assisted Total Knee Arthroplasty and the DePuy VELYS™ Robotic-Assisted Solution for Total Knee Arthroplasty.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- FJS-12 Knee
研究概览
简要总结
The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:
- Will the patient reported outcomes differ between the two groups?
- Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken.
详细描述
The purpose of this study is to compare two different total knee arthroplasty (TKA) robotic assisted (RA) devices. This study will compare patient reported outcome measures prior to and after surgery. These surveys will be used determine if there are differences in patient recovery after TKA depending on the robot used. Radiographs will also be taken and used to compare component positioning. Intraoperative data will be collected to compare OR efficiency of the two systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be a candidate for primary TKA (either Stryker Triathlon with MAKO Robotic-Arm or DePuy Attune with VELYS Robotic-Assistance).
- •Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of information to the Sponsor.
- •Individuals who are willing and able to complete follow up visits, questionnaires, and radiographic evaluations as specified by the study protocol.
- •Individuals who are male or non-pregnant female age 18-80 years at time of device implantation.
- •Patient has a diagnosis of primary osteoarthritis or degenerative joint disease of the knee.
排除标准
- •Patient has a Body Mass Index (BMI) >
- •Patient has been diagnosed with osteoporosis or displays poor bone quality per the discretion of the investigator.
- •Patient has an active or suspected latent infection in affected knee joint. Patient has neuromuscular or neurosensory deficiency.
- •Patient is diagnosed with systemic disease or metabolic disorder (e.g., Lupus, Charcot's. Paget's).
- •Subject is a woman who is pregnant or lactating.
- •Patient has a contralateral amputation.
- •Patient's affected knee has a flexion contracture greater than 15 degrees.
- •Patient has history of post operative arthrofibrosis.
- •Patient's affected knee has a partial knee arthroplasty.
- •Patient has undergone contralateral TKA within the last three months.
- •Patient is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims.
- •Patient who is bedridden per the discretion of the investigator.
- •Patient has a medical condition with less than 2 years of life expectancy.
结局指标
主要结局
FJS-12 Knee
时间窗: 1 year
Forgotten Joint Score
KOOS JR
时间窗: 1 year
Knee injury and Osteoarthritis Outcome Score for Joint Replacement
KSS
时间窗: 1 year
Knee Society Score
次要结局
- Operative step time(Intraoperative)