A Prospective Study to Examine Patient Satisfaction, Function, and Limb Alignment Outcomes for Mako Versus Non-Mako Total Knee Replacements
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Patient Reported Forgotten Joint Score (FJS)
研究概览
简要总结
This study aims to see if outcomes for patients that receive the traditional total knee replacement surgical technique are different than the outcomes for patients that receive robot-assisted total knee replacement. The outcomes we will be tracking include:
- Patients' self-reported awareness of their artificial joints during activities of daily living;
- Patient's self-reported pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life;
- Patients' self-reported general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health;
- The accuracy of implant placement and limb alignment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI
- •Willing to provide informed consent, participate in study, and comply with study protocol
排除标准
- •Pregnant or contemplating pregnancy prior to surgery;
- •Worker's compensation or personal injury related to knee (clinical outcomes have been shown to be less predictable and often poorer in this patient group; there may also exist potential issues with reimbursement)
- •Post-traumatic arthropathy (clinical outcomes have been shown to be less predictable; pre-operative deformity and risk factors are greater and difficult to propensity-match between groups)
- •Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans
研究组 & 干预措施
Robot Assisted Total Knee Replacement
In addition to expert judgment and hand-eye coordination, the surgeon also relies on a robot in making cuts within the pre-determined diseased areas of the joints and placing the implants. This is made possible by uploading 3-dimensional (3D) images of the knee joints into the robot prior to surgery. The robot uses these 3D images to guide the surgeon during the procedure. The 3D images are obtained from a computerized tomography (CT) scan that combines a series of X-ray images taken from different angles to create cross-sectional images of the bones.
干预措施: Robot Assisted Total Knee Replacement (Procedure)
Traditional Total Knee Replacement
The traditional method where the surgeon employs mechanical guides, expert judgment, and natural hand-eye coordination in making the necessary cuts to prepare the bone for the implant as well as in placing the implant.
干预措施: Traditional Total Knee Replacement (Procedure)
结局指标
主要结局
Patient Reported Forgotten Joint Score (FJS)
时间窗: 1 year
The FJS is a self-completed 12-item questionnaire used to assess patients' awareness of their artificial joint during activities of daily living on an awareness scale of 0 (never) to 4 (mostly)
次要结局
- Patient Reported Knee Injury and Osteoarthritis Outcome Score (KOOS)(1 year)
- Patient Reported Veterans Rand 12-item Health Survey Score (VR-12)(1 year)
- The Mechanical Alignment of the Post-operative Limb(6 weeks postoperatively)