Eijking Henriëtte M, Dorling Isobel M, van Haaren Emil H, Hendrickx Roel, Nijenhuis Thijs, Schotanus Martijn G M, Bouwman Lee, Most Jasper, Boonen Bert
Excellence Center for Hip & Knee Arthroplasty, Department of Orthopedic Surgery, Zuyderland Medical Center, Heerlen, The Netherlands.
Department Clinical Engineering, Faculty of Science and Engineering, Medicine and Life Sciences (FHML), Maastricht University, Maastricht, The Netherlands.
J Orthop Surg Res. 2025 Jan 15;20(1):47. doi: 10.1186/s13018-024-05427-y.
In 2020, 368 million people globally were affected by knee osteoarthritis, and prevalence is projected to increase with 74% by 2050. Relatively high rates of dissatisfactory results after total knee arthroplasty (TKA), as reported by approximately 20% of patients, may be caused by sub-optimal knee alignment and balancing. While mechanical alignment has traditionally been the goal, patient-specific alignment strategies are gaining interest. Robotic assistance could potentially facilitate implementation of these alignment strategies through data-based surgical planning, accurate execution of the surgical plan and validation. The clinical value of surgical assistance in diverging from mechanical alignment remains to be investigated. In the present study, robotic-assisted TKA will be performed to pursue inverse kinematic alignment (iKA) within predefined boundaries, focusing on restoring native tibia joint line.
This randomized controlled trial evaluates clinical effectiveness of robotic-assisted TKA (ROSA Knee System, Zimmer Biomet, Montreal, Quebec, Canada) aiming for iKA compared to conventional TKA aiming for mechanical alignment. A total of 150 participants will be randomized (1:1) to either treatment to provide an 80% power for a 4.8-point clinically important difference in the primary outcome measure, the Oxford Knee Score (OKS) 12 months after surgery. Allocation was achieved using computer-based randomization. Outcomes will be analyzed using linear mixed models with time and group as main factors and interaction-term. Secondary outcomes include clinical metrics (leg alignment, implant and patient survival), surgical parameters (adverse events, surgery duration, blood loss, hospital stay length, medication use), patient-reported outcomes (symptoms, quality of life, pain), mobility and physical activity measurements, metabolic syndrome, cost-efficacy, and gait and continuous glucose monitoring.
This study has been approved by the Medical Ethical Committee Zuyd and Zuyderland Medical Centre (NL79161.096.21/METCZ20220006), September 2022.
NCT05685693 (clinicaltrials.gov).
2020年，全球有3.68亿人受膝关节骨关节炎影响，预计到2050年患病率将增加74%。全膝关节置换术（TKA）后约20%的患者报告结果不尽人意，这一比例相对较高，可能是由于膝关节对线和平衡欠佳所致。传统上，机械对线一直是目标，但针对患者的对线策略正受到关注。机器人辅助可能通过基于数据的手术规划、手术计划的精确执行和验证，促进这些对线策略的实施。手术辅助偏离机械对线的临床价值仍有待研究。在本研究中，将进行机器人辅助TKA，以在预定义边界内实现逆运动学对线（iKA），重点是恢复天然胫骨关节线。
本随机对照试验评估与旨在实现机械对线的传统TKA相比，旨在实现iKA的机器人辅助TKA（ROSA膝关节系统，捷迈邦美，加拿大魁北克省蒙特利尔）的临床有效性。总共150名参与者将按1:1随机分组，以在术后12个月的主要结局指标牛津膝关节评分（OKS）上实现4.8分的临床重要差异的80%检验效能。使用基于计算机的随机化进行分配。将使用以时间和组为主要因素以及交互项的线性混合模型分析结果。次要结局包括临床指标（下肢对线、植入物和患者生存率）、手术参数（不良事件、手术持续时间、失血、住院时间、药物使用）、患者报告的结局（症状、生活质量、疼痛）、活动度和身体活动测量、代谢综合征、成本效益以及步态和连续血糖监测。
本研究已获得祖德医疗伦理委员会和祖德兰德医疗中心批准（NL79161.096.21/METCZ20220006），2022年9月。
NCT05685693（clinicaltrials.gov）。
