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
- 1
- 主要终点
- Feasibility- Recruitment
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
- •Adult (18+)
- •Unicompartmental knee OA with or without concomitant patellofemoral OA, requiring surgical treatment
- •Two study surgeons independently agree that the patient is eligible for either treatment group
排除标准
- •Inability to provide informed consent (e.g. cognitive disability, language barrier)
- •Revision knee surgery
- •Simultaneous bilateral knee surgery
- •Previous major knee surgery or trauma
- •The robot or required components are unavailable (e.g. technical difficulties, robot-specific disposables out of stock)
- •A CT scan cannot be obtained prior to surgery
- •Patient does not wish to participate
研究组 & 干预措施
Standard total knee arthroplasty
Participants who are randomized to the control group will undergo TKA according to local standard of care. The choice of implant and use of bone cement will be recorded but left to the surgeon's discretion according to their standard practice.
干预措施: Total knee arthroplasty (Procedure)
Robot-assisted partial knee arthroplasty
Participants with isolated medial or isolated lateral compartment OA who are randomized to the intervention group and have one affected knee compartment will receive a robot-assisted unicompartmental knee arthroplasty (UKA). If the patient has medial or lateral OA plus patellofemoral OA they will receive a bicompartmental knee arthroplasty (BiKA) consisting of a two simultaneous UKAs. The partial knee replacement procedures will be performed using the Mako RIO robotic arm (Stryker) according to the manufacturer's instructions. The choice of implant and use of bone cement will be recorded but will be left to the surgeon's discretion. Surgeons will resurface the patella if the patellar cartilage meets Outerbridge grade 3 or 4 criteria
干预措施: Robot-assisted partial knee arthroplasty (Procedure)
结局指标
主要结局
Feasibility- Recruitment
时间窗: 12 months
The number of patients recruited during a 12 month period
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
次要结局
- Adverse events(12 months post-surgery)
- 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)