Department of Orthopaedics, University of Miami Miller School of Medicine, Miami, FL, 33136, USA.
Department of Orthopedic Surgery, University of Miami/Jackson Memorial Hospital, 1400 NW 12th Ave, Miami, FL, 33136, USA.
Arch Orthop Trauma Surg. 2023 Mar;143(3):1651-1661. doi: 10.1007/s00402-022-04393-6. Epub 2022 Mar 3.
Fully hydroxyapatite-coated titanium alloy double-tapered stems have been successful implant designs for THA. The Novation Element Stem (Exactech, Gainesville, FL) is one of several of these implants following a modified Corail design philosophy. Although a great deal is known about the results of the Corail stem, little is known about the more recent Corail-inspired implants. The authors evaluated the clinical outcomes, radiographic findings and survival statistics of the collarless version of the Element Stem when used routinely in a diverse patient population.
A retrospective review was performed for all primary THR cases from 2010 to 2018. Patient demographics and HHS/OHS/patient satisfaction scores were obtained. Radiographs were evaluated for stem subsidence, radiolucencies, and bone responses to the implant.
One hundred and fifty seven Element Stems were implanted with greater than 2 years of radiographic follow-up, while 105 Element Stems implanted during the study period had a survival of 5 years or more. Average HHS was 91.7 and average OHS was 44.0. 54 of 157 hips had radiolucencies, all of which included a proximal zonal radiolucency. Average subsidence was 3.33 mm; 18 hips had subsidence > 4 mm. There were 8 revisions for: aseptic loosening (4), trauma-related peri-prosthetic fractures, and early proximal-medial fractures. At 5 years, the all-cause survival rate is 92.4%, 96.2% based only on aseptic loosening and 98.1% based only on proximal medial fractures.
Clinical outcomes using the collarless Novation Element Stem are good, but early proximal medial fracture is still a factor in patients with poor-quality bone. Proximal radiolucencies progressing to aseptic loosening post-operatively are also a concern. The 11.5% rate of subsidence is comparable to other fully HA-coated collarless stems. This study provides a thorough critical analysis of outcomes and midterm survival data of this dual tapered-wedge fully HA-coated collarless stem used routinely in a diverse patient population.
全羟基磷灰石涂层钛合金双锥形柄已成为 THA 的成功植入设计。Novation Element 柄(Exactech,盖恩斯维尔,FL)是遵循改良 Corail 设计理念的几种此类植入物之一。尽管人们对 Corail 柄的结果了解很多,但对最近更受启发的 Corail 植入物却知之甚少。作者评估了在不同患者人群中常规使用无领版 Element 柄的临床结果、影像学发现和生存统计数据。
对 2010 年至 2018 年所有初次 THR 病例进行回顾性分析。获得患者人口统计学和 HHS/OHS/患者满意度评分。评估影像学上的柄沉降、透亮线和骨对植入物的反应。
157 个 Element 柄植入后有超过 2 年的影像学随访,而在研究期间植入的 105 个 Element 柄有 5 年或更长时间的生存。平均 HHS 为 91.7,平均 OHS 为 44.0。157 个髋关节中有 54 个有透亮线,均包括近端区域透亮线。平均沉降量为 3.33mm;18 个髋关节沉降量>4mm。有 8 个翻修病例:无菌性松动(4)、与创伤相关的假体周围骨折和早期近端内侧骨折。5 年时,所有原因的生存率为 92.4%,仅基于无菌性松动的生存率为 96.2%,仅基于近端内侧骨折的生存率为 98.1%。
使用无领 Novation Element 柄的临床结果良好,但早期近端内侧骨折仍是骨质量差患者的一个因素。术后近端透亮线进展为无菌性松动也是一个关注点。11.5%的沉降率与其他全 HA 涂层无领锥形柄相当。本研究对常规应用于不同患者人群的双锥形全 HA 涂层无领锥形柄的结果和中期生存数据进行了全面的批判性分析。