Robotic Assisted Surgery Comparing Personalized Alignment Versus Mechanical Alignment of Total Knee Arthroplasty - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- MTPM
研究概览
简要总结
Robotic knee surgery makes it possible to adopt different alignment philosophies in total knee arthroplasty. The classical operation where the knee is placed in a neutral manner, the so called mechanical alignment, has been used for decades. The kinematical alignment has recently won popularity. With this technique the focus is to render the natural knee anatomy even if this means to end up with a varus or valgus position. In this study, the investigators will compare the mechanical alignment and kinematical alignment and test the patients clinically and with a special CT scan to see if this technique gives equal or better longevity of the implants.
详细描述
Mechanical alignment (MA) has for many years been the most used surgical alignment technique in total knee arthroplasty (TKA). This means that regardless of constitutional native anatomy (i.e. valgus or varus), one strives to achieve a neutral coronal knee axis on postoperative x-rays (Hip-Knee-Ankle angle, HKA). To achieve MA, the cuts are made perpendicular to the mechanical axis, and subsequent soft tissue balancing is performed if necessary. However, many patients do not have a neutral knee alignment before they develop osteoarthritis. Several authors therefore advocate the personalized alignment (kinematic, KA or functional alignment, FA), where the aim is to restore the patient's original pre-arthritis anatomy and joint line. This means that tibial component placement in varus or valgus is accepted, despite the possible result of a postoperative non-neutral HKA axis. Studies indicate that good clinical results can be achieved in terms of range of motion (ROM) and patient reported outcome measures (PROMs) with these techniques, but it has not been tested properly in terms of activity measurements, strength testing or migration of implants. There is diversity in the literature regarding whether tibial component with too much deviation from a neutral axis can lead to increased migration and eventually aseptic solution. To date, only a few trials, with diverging results, have assessed migration of the implants implanted with KA or FA. The methods are so far perceived as controversial, despite the widespread use.
KA or FA can be performed by manual conventional surgery; however, the newly introduced robotic assisted surgery probably yields higher accuracy and precision of the cuts during surgery. This makes robotic assisted surgery well suited for personalized surgery. Yet, it is claimed that because of diversity of the different features for planning and executing the surgery, each system should be evaluated separately, and not as a group. The investigators therefore planned this study to assess the efficacy of robotic assisted surgery comparing MA and personalized alignment (PA) techniques.
Aims of the trial
- Evaluate the clinical outcomes of patients who have had TKA with PA and compare it with conventional MA.
- Analyse and compare the in vivo stability over time of TKA operated with PA vs. MA using CT- based radiostereometric analysis (CT-RSA).
- Evaluate the postoperative position of the implants using two different alignment philosophies.
Objective Perform TKAs on patients using ROSA® Knee System (Zimmer Biomet, Warsaw, Indiana USA) robotic assisted surgery and randomize the patients to either PA or MA.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patient, nurses and physiotherapists are blinded. Surgeon is of course not blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •femoro-tibial or patello-femoral osteoarthritis (Kellgren-Lawrence, K-L) grade 2-4 with persistent pain, referred to Kristiansund Hospital for primary TKA
排除标准
- •serious psychiatric disorders
- •drug abuse
- •patients not able to speak and read Norwegian language making them noncompliant or unable to perform an informed consent
- •Patients with ongoing cancer therapy
- •Patients with ASA (The American Society of Anesthesiologists physical status class risk stratification system) classification >3
- •Patients in the need of walking aid devices
- •Patients in need of primary revision arthroplasty or more than 15 degrees of varus or 5 degrees of valgus on preoperative HKA images.
研究组 & 干预措施
Mechanical alignment
Patients are operated with ROSA robot and mechanical alignment
干预措施: Total knee replacement (Procedure)
Personalized alignment
Patients are operated with ROSA robot and kinematic alignment
干预措施: Total knee replacement (Procedure)
结局指标
主要结局
MTPM
时间窗: 2 years
Maximum Total Point Motion measured by CT -based RSA in millimeters.
次要结局
- XYZ rotation(2 years)
- XYZ translation(2 years)
- Steps per day(1 year and 2 years)
- Maximal voluntary contraction flexion(1 and 2 years)
- KOOS score(1 and 2 years)
- VAS(1 and 2 years)
- Walking speed(1 and 2 years)
- Stair climbing(1 and 2 years)
- Sit to stand test(1 and 2 years)
- Eq-5D(1 and 2 years)
- Maximal voluntary contraction extension(1 and 2 years)
- Maximal voluntary contraction(1 and 2 years)
- FJS(1 and 2 years)