一种由高度交联聚乙烯注入维生素 E 制成的无水泥弹性单体杯的概念：使用 EBRA 进行迁移和磨损的放射学分析以及中期随访的临床结果。
The concept of a cementless isoelastic monoblock cup made of highly cross-linked polyethylene infused with vitamin E: radiological analyses of migration and wear using EBRA and clinical outcomes at mid-term follow-up.
机构信息
Department of Orthopaedic Surgery, St. Josefs Hospital Wiesbaden, Beethovenstr. 20, 65189, Wiesbaden, Germany.
Department of Orthopaedics and Traumatology, University Medical Centre of the Johannes Gutenberg-University of Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.
出版信息
BMC Musculoskelet Disord. 2021 Jan 23;22(1):107. doi: 10.1186/s12891-021-03981-8.
BACKGROUND
The newest generation of cementless titanium-coated, isoelastic monoblock cup with vitamin E-blended highly cross-linked polyethylene (HXLPE) was introduced to the market in 2009. The aim of the present study was to obtain mid-term follow-up data including migration and wear analyses.
METHODS
This prospective study investigated 101 primary total hip arthroplasty (THA) cases in 96 patients treated at a single institution. Patients were allowed full weight-bearing on the first day postoperatively. Harris hip score (HHS) and pain and satisfication on a visual analogue scale (VAS) were assessed at a mean follow-up of 79.0 months. Migration and wear were assessed using Einzel-Bild-Roentgen-Analyse (EBRA) software. Radiological acetabular bone alterations and complications were documented.
RESULTS
At mid-term follow-up (mean 79.0 months, range: 51.8-101.7), 81 cases with complete clinical and radiological data were analyzed. Utilisable EBRA measurements were obtained for 42 hips. The mean HHS was 91.1 (range 38.0-100.0), VAS satisfaction was 9.6 (range 6.0-10.0), VAS rest pain was 0.2 (range 0.0-4.0), and VAS load pain was 0.6 (range 0.0-9.0). Mean migration was 0.86 mm (range: 0.0-2.56) at 24 months and 1.34 mm (range: 0.09-3.14) at 5 years, and the mean annual migration rate was 0.22 (range: - 0.24-1.34). The mean total wear was 0.4 mm (range: 0.03-1.0), corresponding to a mean annual wear rate of 0.06 mm per year (range: 0.0-0.17). Radiographic analysis did not reveal any cases of osteolysis, and no revision surgeries had to be performed.
CONCLUSIONS
After using vitamin-E blended HXLPE in cementless isoelastic monoblock cups, there were no obvious signs of osteolysis or aseptic loosening occurred. No patients required revision surgery after mid-term follow-up. Cup migration and wear values were well below the benchmarks considered predictive for potential future failure.
TRIAL REGISTRATION
The trial registration number on ClinicalTrials.gov : NCT04322916 (retrospectively registered at 26.03.2020).
背景
最新一代的无水泥钛涂层、等弹性整体式杯与维生素 E 混合的超高交联聚乙烯（HXLPE）于 2009 年推向市场。本研究旨在获得中期随访数据，包括迁移和磨损分析。
方法
本前瞻性研究调查了 96 例患者中的 101 例初次全髋关节置换（THA）病例，这些患者均在一家机构接受治疗。术后第一天允许患者完全负重。平均随访 79.0 个月时，采用 Harris 髋关节评分（HHS）和视觉模拟评分（VAS）评估疼痛和满意度。采用 Einzel-Bild-Roentgen-Analyse（EBRA）软件评估迁移和磨损。记录髋臼骨放射性改变和并发症。
结果
在中期随访（平均 79.0 个月，范围：51.8-101.7）时，分析了 81 例具有完整临床和影像学数据的病例。42 个髋关节获得了可使用的 EBRA 测量值。平均 HHS 为 91.1（范围 38.0-100.0），VAS 满意度为 9.6（范围 6.0-10.0），VAS 静息疼痛为 0.2（范围 0.0-4.0），VAS 负重疼痛为 0.6（范围 0.0-9.0）。24 个月时平均迁移为 0.86mm（范围：0.0-2.56），5 年时为 1.34mm（范围：0.09-3.14），平均年迁移率为 0.22（范围：-0.24-1.34）。平均总磨损量为 0.4mm（范围：0.03-1.0），相当于每年 0.06mm 的平均磨损率（范围：0.0-0.17）。放射学分析未发现任何骨溶解迹象，也无需进行翻修手术。
结论
在无水泥等弹性整体式杯使用维生素 E 混合的 HXLPE 后，没有明显的骨溶解或无菌性松动迹象。中期随访后，无患者需要进行翻修手术。杯迁移和磨损值远低于可能导致未来潜在失败的预测基准值。
临床试验注册
ClinicalTrials.gov 上的试验注册号：NCT04322916（2020 年 3 月 26 日回顾性注册）。
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