Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Feasibility- Participant retention
研究概览
简要总结
This is a pilot randomized trial to assess the feasibility of a definitive trial to determine the effect of robot-assisted partial knee replacements versus standard total knee replacements.
详细描述
Knee osteoarthritis (OA) pain is an important source of morbidity and cost to the health care system. Over 60,000 knee replacement surgeries are performed in Canada every year, making it the second most common surgery. Our institution (St. Joseph's Healthcare Hamilton) is the first hospital in Canada to purchase a Mako RIO orthopaedic robot to assist with performing knee replacements. The knee is divided into three compartments, and one, two, or all three compartments can become arthritic. Over 90% of patients with end-stage knee OA receive a total knee replacement (also known as total knee arthroplasty or TKA) even if they have one or two healthy knee compartments. Partial knee replacements are an option for these patients but these procedures are very technically demanding and associated with a higher risk of implant failure. For this reason, few surgeons are experts at partial knee replacements. We believe that we can use robotic technology to make it easier for surgeons to perform partial replacements more accurately, thereby increasing the quality and survivorship of partial knee replacements. This may lead to better patient-important outcomes like return to activity, pain, and satisfaction, and eventually better access to high-quality partial knee replacements for Canadians. This will be the first study to evaluate total knee replacements (standard care) versus robot-assisted partial knee replacements, and could lead to greater uptake of robotic technology in orthopaedics and a shift toward anatomy-sparing partial knee replacements.
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
盲法说明
Surgeons cannot be blinded to treatment group. It would not be feasible to blind the health care team and patients because the incisions and imaging are visually distinguishable. We will attempt to minimize bias in subjective measures by presenting patients with balanced information on each treatment group prior to the trial. All participants will receive a computed tomography (CT) scan prior to surgery to maintain blinding and to give surgeons additional information about 3 dimensional modelling for implant placement. Data analysts will be blinded to treatment allocation. An independent outcomes assessor will independently review radiographic alignment for each patient and review relatedness of adverse events and re-operations. The independent assessor cannot be blinded because imaging is visually distinguishable.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasibility- Participant retention
时间窗: 12 months
Number of patients completing the study
Feasibility- Treatment compliance
时间窗: 12 months
The number of crossovers during a 12 month period
Feasibility- Recruitment
时间窗: 12 months
The number of patients recruited during a 12 month period
次要结局
- Healthcare resource use (for cost-effectiveness)(12 months post-surgery)
- Rage of motion (ROM)(6 weeks post-surgery)
- Forgotten joint score(12 months post-surgery)
- Quality of life- EQ-5D(12 months post-surgery)
- Persistent post-surgical pain (PPSP)(12 months post-surgery)
- Patient global impression of change score(12 months post-surgery)
- Return to function questionnaire(12 months post-surgery)
- Short-term implant survival(12 months post-surgery)
- Gait walking mechanics analysis(12 months post-surgery)
- Knee alignment(Post-surgery)
- Oxford knee score(12 months post-surgery)
- Adverse events(12 months post-surgery)