Killen Cameron J, Murphy Michael P, Hopkinson William J, Harrington Melvyn A, Adams William H, Rees Harold W
Loyola University Medical Center, Department of Orthopaedic Surgery and Rehabilitation, 2160 S. First Avenue, Maguire Suite 1700, Maywood, IL, 60153, USA.
Baylor College of Medicine, Department of Orthopaedic Surgery and Rehabilitation, 1 Baylor Plaza, Houston, TX, 77030, USA.
J Clin Orthop Trauma. 2020 Jan-Feb;11(1):154-159. doi: 10.1016/j.jcot.2019.03.019. Epub 2019 Mar 29.
Total knee arthroplasty (TKA) with fixed-bearing (FB) implants have demonstrated impressive functional results and survival rates. Meanwhile, rotating-platform (RP) constructs have biomechanically shown to reduce polyethylene wear, lower the risk of component loosening, and better replicate anatomic knee motion. There is growing question of the clinical impact these design changes have long-term.Questions/purposes: The aim of this double-blinded prospective randomized trial was to compare function and implant survival in patients who received either FB or RP press-fit condylar Sigma (PFC Sigma, DePuy, Warsaw, IN) total knee replacements at a minimum follow-up of twelve years.
Patient reported outcome measures used included the functional Knee Society Score, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores, Medical Outcomes Short Form-36 (SF-36) score, and satisfaction assessment on a four-point Likert scale. The data was collected from times preoperative, two-years, and final encounter (mean 13.95 years). A total of 28 RP and 19 FB knees (58.8%) were analyzed at the final follow-up.
Among all patients, KSS and WOMAC scores statistically improved from pre-op to 2-year, while KSS statistically worsened from 2-year to final follow-up. The RP group averaged better follow-up scores in all assessments at the final follow-up with exception of overall satisfaction. There was no statistically significant difference in the functional Knee Society Score, Short Form-36, WOMAC scores, patient satisfaction or implant survival between the two groups at any measured period.
The use of a fixed-bearing or rotating-platform design does not convey significant superiority in terms of function or implant longevity at a minimum twelve years after total knee arthroplasty.
Level I, Experimental study, randomized controlled trial (RCT).
采用固定平台（FB）植入物的全膝关节置换术（TKA）已展现出令人瞩目的功能效果和生存率。同时，旋转平台（RP）结构在生物力学上显示可减少聚乙烯磨损，降低组件松动风险，并更好地复制膝关节的解剖运动。这些设计改变的长期临床影响问题日益凸显。
问题/目的：这项双盲前瞻性随机试验的目的是比较接受FB或RP压配髁型Sigma（PFC Sigma，DePuy，华沙，印第安纳州）全膝关节置换术的患者在至少十二年随访期内的功能和植入物生存率。
使用的患者报告结局指标包括膝关节功能协会评分、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分、医学结局简明36项量表（SF-36）评分以及四分李克特量表满意度评估。数据收集于术前、两年及最终随访（平均13.95年）。在最终随访时，共分析了28个RP膝关节和19个FB膝关节（58.8%）。
在所有患者中，膝关节功能协会（KSS）和WOMAC评分从术前到两年时在统计学上有所改善，而KSS从两年到最终随访时在统计学上有所恶化。除总体满意度外，RP组在最终随访的所有评估中平均随访评分更好。在任何测量时期，两组之间的膝关节功能协会评分、简明36项量表、WOMAC评分、患者满意度或植入物生存率均无统计学显著差异。
在全膝关节置换术后至少十二年，使用固定平台或旋转平台设计在功能或植入物寿命方面未显示出显著优势。
I级，实验性研究，随机对照试验（RCT）。
