Assessment of Conventional and Patient-specific Instrumentation in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluating the Change in Implant Fixation assessed using RSA imaging
研究概览
简要总结
This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging to determine whether patient-specific instrumentation for total knee arthroplasty (replacement) has an effect on implant loosening compared to conventional instrumentation. Secondary objectives will include assessment of post-operative implant alignment, patient satisfaction, operative time and surgical instrument use, cost, and environmental impact.
详细描述
This is a prospective randomized controlled trial which will enroll 50 patients undergoing total knee replacement surgery. All study patients will undergo an MRI prior to surgery. Half (25)of these patients will be randomized to have their MRI used to develop a patient-specific instrument to be used during their surgery. The other half (25) will have conventional instrumentation (CI) used for their knee replacement surgery.
All patients will have the same type of knee implant used for their total knee replacement (Genesis II posterior stabilized (Smith & Nephew).
Patients will not know which group they have been randomized to. For patients randomized into the patient-specific randomization group, If the surgeon is not happy with the patient-specific instrumentation, they have the option to switch to conventional instrumentation at any time during the surgery.
• Length of operation, number of instruments used, amount of OR room waste and number and type of adjustments to the patient specific instrumentation will be tracked.
During the surgery, all patients in the study will have tantalum marker beads placed in the bone surrounding their knee replacement. These beads will be used as markers to measure implant fixation over the next two years. All patients will undergo a special type of x-ray imaging called RSA imaging to quantify implant fixation over time.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing primary total knee replacement surgery
- •No previous knee hardware (ie.Uni-Knees, or high tibial osteotomy)
- •BMI < 40
- •Study patients should live within 100 km of our facility to ensure availability for follow-up
排除标准
- •Pregnancy or considering pregnancy
- •BMI > 40
- •Unable to undergo MRI screening
研究组 & 干预措施
Patient-Specific Instrumentation
Patients to have a total knee replacement surgery completed using Patient-Specific Instrumentation
干预措施: Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation (Device)
Traditional Instrumentation
Patients to have a total knee replacement surgery done using traditional instrumentation.
结局指标
主要结局
Evaluating the Change in Implant Fixation assessed using RSA imaging
时间窗: 2 weeks, 6 weeks, 3 months 6 months, 1 year, 2 years
Model based RSA will be used to measure the migration of the implant components relative to the bone between all time points.
次要结局
- Patient Outcomes including Satisfaction(Preoperatively, 1 year, 2 year)
研究者
Douglas Naudie
Orthopaedic Surgeon
Lawson Health Research Institute