Texas Center for Joint Replacement, Plano, Texas.
Plano Orthopedic Sports Medicine & Spine Center, Plano, Texas.
J Arthroplasty. 2018 Mar;33(3):677-683. doi: 10.1016/j.arth.2017.10.015. Epub 2017 Oct 16.
FDA approval for the Oxford phase III device was approved for use in the United States in 2004. This study seeks to provide the first long-term, large patient sample size, Oxford phase III multi-site survivorship study in the United States, investigating patient reported outcomes of pain and function, while also providing an in-depth analysis of causes for revision, and finally addressing recent advancements that can help aid the unicompartmental knee arthroplasty (UKA) process and further improve partial knee survivorship.
Between July 2004 and December 2006, 5 surgeons from around the United States performed medial UKA through the minimally invasive surgical approach, on 825 knees in 695 patients. This was a consecutive series of primary UKAs using the phase III mobile bearing; cemented Oxford Knee (Zimmer Biomet, Warsaw, IN), implanted utilizing phase III instrumentation. UKA survivorship considered all revisions as the end point. Implant survivorship eliminated revisions at which the original Oxford implant was determined to be well fixated and functional intra-operatively.
A total of 93 knees were revised in this study. Mean follow-up was 9.7 years (6-12). Implant survivorship at year 10 was 90% (confidence interval 2.7%). UKA survivorship at year 10 was 85% (confidence interval 3.8%). Average preoperative American Knee Society Score (knee score) was 49 and rose to 90 postoperatively (standard deviations 16 and 18, respectively). Average preoperative American Knee Society Score (function score) was 55 and rose to 77 postoperatively (standard deviations 15 and 28, respectively).
This was the first large-scale, 10-year, multi-site follow-up of the Oxford mobile-bearing medial UKA undertaken in the United States, displaying good survivorship and excellent patient outcomes.
FDA 于 2004 年批准了牛津 III 期设备在美国的使用。本研究旨在提供美国首个长期、大规模的牛津 III 期多中心生存研究,调查患者报告的疼痛和功能结果,同时深入分析翻修原因,并最终探讨最近的进展,以帮助辅助单髁膝关节置换术(UKA)过程并进一步提高部分膝关节的生存率。
2004 年 7 月至 2006 年 12 月,来自美国各地的 5 位外科医生采用微创外科入路对 695 例患者的 825 膝进行了内侧 UKA。这是一系列连续的原发性 UKA,使用第三代活动衬垫;骨水泥牛津膝关节(Zimmer Biomet,印第安纳州华沙),采用第三代器械植入。UKA 生存率将所有翻修作为终点。植入物生存率排除了那些最初的牛津植入物被认为是固定良好且术中功能正常的翻修。
本研究共对 93 膝进行了翻修。平均随访时间为 9.7 年(6-12 年)。第 10 年的植入物生存率为 90%(置信区间 2.7%)。第 10 年的 UKA 生存率为 85%(置信区间 3.8%)。术前平均美国膝关节协会评分(膝关节评分)为 49,术后升高至 90(标准差分别为 16 和 18)。术前平均美国膝关节协会评分(功能评分)为 55,术后升高至 77(标准差分别为 15 和 28)。
这是美国首次进行的长达 10 年、多中心的牛津第三代活动衬垫内侧 UKA 大规模随访,显示出良好的生存率和优秀的患者结果。