A Prospective, Randomised Controlled Trial Evaluating Total Knee Replacement With the Stryker Triathlon Primary Total Knee System Performed Using Stryker's Robotic-arm Assisted Surgery System, Mako, Compared to Bicompartmental Knee Replacement With Restoris MCK Multicompartmental Knee System Performed Using Stryker's Robotic-arm Assisted Surgery System, Mako
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Oxford Knee Score
研究概览
简要总结
A prospective, randomised controlled trial evaluating Total Knee Replacement with the Stryker Triathlon Primary Total Knee System, compared to Bicompartmental Knee Replacement with Restoris MCK Multicompartmental Knee System performed using Stryker's Robotic-arm assisted surgery system, Mako.
详细描述
This study is a prospective, randomised clinical study comparing clinical outcomes of Knee Replacement using the Oxford Knee Score (OKS), in patients receiving either Bicompartmental Knee Replacement performed using Stryker's robotic-arm assisted surgery system Mako, to Total Knee Replacement using the Triathlon Total Knee System performed with either conventional instrumentation or navigation. Functional and radiographic outcomes will be additionally collected as part of this study.
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
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
- •The patient is a suitable candidate for a Bicompartmental Knee Replacement and has moderate to severe patellofemoral wear and medial compartment wear (surgeons discretion)
- •The patient has no fixed flexion greater than 10 degrees.
- •The patient has maximal flexion greater than 100 degrees
- •The patient has a passively correctable varus deformity
- •The patient has a functionally Intact Anterior Cruciate Ligament (ACL.)
- •The patient has no significant patellofemoral malalignment
- •The patient has negligible lateral compartment degeneration with no appreciable loss of cartilage height (surgeon's discretion).
- •The patient has pain that is not localised to the medial compartment only
- •The patient is a male or non-pregnant female.
- •The patient has signed the study specific, Human Research Ethics Committee (HREC)- approved Informed Consent document and is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations
排除标准
- •The patient has a clinically deficient ACL and cruciate and collateral ligament insufficiency on CT arthrogram.
- •The patient is undergoing revision surgery
- •The patient has greater than 10° of hyperextension, greater than 10° of varus or valgus deformity, greater than 10° Flexion Contracture
- •The patient has active, local infection or previous intra-articular infection
- •The patient has skeletal immaturity
- •The patient is without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
- •The patient's weight, age or activity level might cause extreme loads and early failure of the system (surgeons discretion).
- •The patient has a systemic or local condition that would limit the ability to assess the performance of the device e.g. neuromuscular or neurosensory deficiency, disorder leading to progressive bone deterioration (including rheumatoid arthritis and osteoporosis), or patient is immunologically suppressed.
- •Patient has a cognitive impairment, an intellectual disability or a mental illness that is considered by the investigator to inhibit the patient's capacity to consent to research and the ability to participate in it
- •Patients with tricompartmental disease are contraindicated from the study
结局指标
主要结局
Oxford Knee Score
时间窗: pre-op, 6 weeks, 3 months, 12 months, 24 months
Comparing clinical outcomes using the Oxford Knee Score. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.
次要结局
- New Knee Society Score (KSS)(24 months/ 2years)
- Forgotten Joint Score (FJS)(24 months/ 2years)
- VAS Pain(24 months/ 2years)
- Health Related Quality of Life EQ-5D(24 months/ 2years)
- Length of Hospital Stay(6 weeks)
- Incidence of Loosening, Reoperation and Revision(6 weeks, 3 months, 12 months, 24 months)