BACKGROUND For the vast majority of displaced femoral neck fractures in older patients, cemented femoral fixation is indicated because it is associated with a lower risk of periprosthetic fracture than cementless fixation. Nevertheless, cementless fixation continues to be utilized with high frequency for hip fractures in the United States. It is therefore helpful to understand the performance of individual cementless brands and models. Although prior studies have compared femoral stems by design type or stem geometry, there may still be a difference in revision risk according to femoral stem brand given the potential differences within design groupings with regard to manufacturing, implantation systems, and implant design nuances among vendors. QUESTIONS/PURPOSES (1) Is there a difference in aseptic revision risk among femoral stem brands in patients ≥ 60 years of age who have displaced femoral neck fractures treated with cementless hemiarthroplasty? (2) Is there a difference in revision for periprosthetic fracture among femoral stem brands in patients ≥ 60 years of age with displaced femoral neck fractures treated with cementless hemiarthroplasty? METHODS A retrospective, comparative, large-database cohort study was conducted using data from Kaiser Permanente's Hip Fracture Registry. This integrated healthcare system covers more than 12 million members throughout eight regions in the United States; membership has been found to be representative of the general population in the areas served. The Hip Fracture Registry collects details on all patients who undergo hip fracture repair within the organization. These patients are then longitudinally monitored for outcomes after their repair, and all identified outcomes are manually validated through chart review. Patients ages ≥ 60 years who underwent unilateral hemiarthroplasty treatment of a displaced femoral neck fracture from 2009 to 2021 were identified (n = 22,248). Hemiarthroplasties for polytrauma, pathologic or open fractures, or patients who had additional surgeries at other body sites during the same stay, as well as those with prior procedures in the same hip, were excluded (21.4% [4768]). Cemented procedures and those with missing or inconsistent implant information (for example, cement used but cementless implant recorded) were further excluded (47.1% [10,485]). To allow for enough events for evaluation, the study sample was restricted to seven stems for which there were at least 300 hemiarthroplasties performed, including four models from DePuy Synthes (Corail®, Summit®, Summit Basic, and Tri-Lock®) and three from Zimmer Biomet (Medial-Lateral [M/L] Taper®, Trabecular Metal®, and Versys® Low Demand Fracture [LD/FX]). The final sample included 5676 cementless hemiarthroplasties: 653 Corail, 402 M/L Taper, 1699 Summit, 1590 Summit Basic, 384 Tri-Lock, 637 Trabecular Metal, and 311 Versys LD/FX. Procedures were performed by 396 surgeons at 35 hospitals. The mean age and BMI for the cohort was 81 years and 24 kg/m2, respectively; most were women (66% [3733 of 5676]) and White (79% [4488 of 5676]). Based on standardized mean differences, we controlled for age, race/ethnicity, American Society of Anesthesiologist (ASA) classification, anesthesia technique, operative year, average annual surgeon hemiarthroplasty volume, and operative year across the seven stem groups. Of the 5676 patients, 7% (378 of 5676) were lost to follow-up through membership termination at a median time of 1.6 years, and 56% (3194 of 5676) of the patients died during study follow-up. A multivariable cause-specific Cox proportional hazards regression model was used to evaluate the risk for aseptic revision with adjustment for age, gender, ASA classification, depression, operating surgeon, deficiency anemias, time from admission to surgery, and average annual surgeon hemiarthroplasty volume. A random intercept was included to address effects from hemiarthroplasties performed by the same surgeon. Risk for revision for periprosthetic fracture was also evaluated as a secondary outcome. RESULTS In the adjusted analysis, the Summit Basic (HR 1.91 [95% confidence interval 1.34 to 2.72]; p < 0.001), the M/L Taper (HR 1.91 [95% CI 1.15 to 3.15]; p = 0.01), and the Versys LD/FX (HR 2.12 [95% CI 1.25 to 3.61]; p = 0.005) had higher aseptic revision risks during follow-up when compared with the Summit. No differences were observed for the Corail (HR 0.57 [95% CI 0.29 to 1.10]; p = 0.09), the Tri-Lock (HR 1.13 [95% CI 0.62 to 2.07]; p = 0.68), or the Trabecular Metal (HR 1.14 [95% CI 0.69 to 1.89]; p = 0.61) compared with the Summit. A higher risk for revision because of periprosthetic fracture was observed with the M/L Taper (HR 2.43 [95% CI 1.29 to 4.58]; p = 0.006) and the Summit Basic (within 3 months of follow-up: HR 1.16 [95% CI 0.60 to 2.25]; p = 0.66; after 3 months of follow-up: HR 2.84 [95% CI 1.36 to 5.94]; p = 0.006) stems when compared with the Summit. CONCLUSION In a cohort of 5676 cementless hemiarthroplasties, we found differences in revision risks among different femoral stem brands. Based on our findings, we recommend against utilization of the Zimmer M/L Taper, DePuy Summit Basic, and Zimmer Versys LD/FX in the treatment of displaced geriatric femoral neck fractures with cementless hemiarthroplasty. Future large registry studies are needed to further elucidate differences in aseptic revision risk among higher performing cementless femoral stems. Although cemented fixation remains the recommended approach based on the best available evidence in hemiarthroplasty treatment of hip fractures, our findings may help to mitigate aseptic revision risk should cementless fixation be chosen. LEVEL OF EVIDENCE Level III, therapeutic study.

中文翻译：

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用于治疗老年股骨颈骨折的非骨水泥半髋关节置换术中使用的股骨柄品牌的性能是否存在差异？


背景 对于绝大多数老年患者移位的股骨颈骨折，骨水泥股骨固定是合适的，因为与非骨水泥固定相比，其假体周围骨折的风险较低。尽管如此，在美国，无骨水泥固定仍广泛用于治疗髋部骨折。因此，了解各个非水泥品牌和型号的性能很有帮助。尽管之前的研究已按设计类型或股骨柄几何形状对股骨柄进行了比较，但考虑到供应商之间的设计分组在制造、植入系统和植入物设计细微差别方面的潜在差异，根据股骨柄品牌，翻修风险仍可能存在差异。问题/目的 (1) 对于年龄 ≥ 60 岁、接受非骨水泥半髋关节置换术治疗的移位股骨颈骨折的患者，不同股骨柄品牌的无菌翻修风险是否存在差异？ (2)对于年龄≥60岁、移位性股骨颈骨折行非骨水泥人工股骨头置换术的患者，不同股骨柄品牌的假体周围骨折翻修是否存在差异？方法 使用 Kaiser Permanente 髋部骨折登记处的数据进行回顾性、比较、大型数据库队列研究。这个综合医疗保健系统覆盖美国八个地区超过 1200 万会员；据发现，成员代表了所服务地区的一般人口。髋部骨折登记处收集组织内所有接受髋部骨折修复的患者的详细信息。然后对这些患者修复后的结果进行纵向监测，并通过图表审查手动验证所有确定的结果。 确定了 2009 年至 2021 年间因移位股骨颈骨折接受单侧半髋关节置换术治疗的年龄 ≥ 60 岁的患者 (n = 22,248)。因多发伤、病理性或开放性骨折而进行的半关节置换术，或在同一住院期间在其他身体部位接受过额外手术的患者，以及在同一髋关节上接受过先前手术的患者均被排除在外 (21.4% [4768])。骨水泥手术和种植体信息缺失或不一致的手术（例如，使用骨水泥但记录了无骨水泥种植体）被进一步排除（47.1% [10,485]）。为了允许足够的事件进行评估，研究样本仅限于 7 个股骨柄，其中至少进行了 300 例半关节置换术，其中包括 DePuy Synthes 的 4 个模型（Corail®、Summit®、Summit Basic 和 Tri-Lock®）和 3 个模型。来自 Zimmer Biomet（内侧-外侧 [M/L] Taper®、Trabeular Metal® 和 Versys® 低需求骨折 [LD/FX]）。最终样本包括 5676 个非骨水泥半关节置换术：653 Corail、402 M/L Taper、1699 Summit、1590 Summit Basic、384 Tri-Lock、637 Trabeular Metal 和 311 Versys LD/FX。手术由 35 家医院的 396 名外科医生进行。该队列的平均年龄和体重指数分别为 81 岁和 24 kg/m2；大多数是女性（66% [5676 中的 3733]）和白人（79% [5676 中的 4488]）。根据标准化平均差异，我们控制了七个干组的年龄、种族/民族、美国麻醉医师协会 (ASA) 分类、麻醉技术、手术年份、平均每年外科医生半髋关节置换术数量和手术年份。在 5676 名患者中，7%（5676 名患者中的 378 名）因中位时间 1.6 年终止会员资格而失去随访，56%（5676 名患者中的 3194 名）患者在研究随访期间死亡。 使用多变量特定原因 Cox 比例风险回归模型来评估无菌翻修的风险，并调整年龄、性别、ASA 分类、抑郁症、手术外科医生、缺乏性贫血、从入院到手术的时间以及平均每年外科医生半关节置换术量。随机截取是为了解决同一外科医生进行的半关节置换术的影响。假体周围骨折翻修的风险也作为次要结果进行评估。结果 在调整后的分析中，Summit Basic（HR 1.91 [95% CI 1.34 to 2.72]；p < 0.001）、M/L Taper（HR 1.91 [95% CI 1.15 to 3.15]；p = 0.01）和与 Summit 相比，Versys LD/FX（HR 2.12 [95% CI 1.25 至 3.61]；p = 0.005）在随访期间具有更高的无菌翻修风险。对于 Corail（HR 0.57 [95% CI 0.29 至 1.10]；p = 0.09）、Tri-Lock（HR 1.13 [95% CI 0.62 至 2.07]；p = 0.68）或小梁金属（P = 0.68），没有观察到差异。与峰会相比，HR 1.14 [95% CI 0.69 至 1.89]；p = 0.61）。使用 M/L Taper（HR 2.43 [95% CI 1.29 至 4.58]；p = 0.006）和 Summit Basic（随访 3 个月内：HR 1.16 [95]）观察到因假体周围骨折而进行翻修的风险较高% CI 0.60 至 2.25]；p = 0.66；3 个月随访后：HR 2.84 [95% CI 1.36 至 5.94]；与 Summit 相比，p = 0.006。结论 在 5676 例非骨水泥股骨头置换术队列中，我们发现不同股骨柄品牌之间的翻修风险存在差异。根据我们的研究结果，我们建议不要使用 Zimmer M/L Taper、DePuy Summit Basic 和 Zimmer Versys LD/FX 通过非骨水泥半髋关节置换术治疗移位的老年股骨颈骨折。 未来需要进行大型登记研究，以进一步阐明性能较高的非骨水泥股骨柄之间无菌翻修风险的差异。尽管基于半髋关节置换术治疗髋部骨折的最佳现有证据，骨水泥固定仍然是推荐的方法，但如果选择非骨水泥固定，我们的研究结果可能有助于减轻无菌翻修风险。证据级别 III 级，治疗研究。