Are There Differences in Performance Among Femoral Stem Brands Utilized in Cementless Hemiarthroplasty for Treatment of Geriatric Femoral Neck Fractures?

IF 4.2 2区 医学 Q1 ORTHOPEDICS
Ishan Shah, Heather A Prentice, Kanu Okike, Ronald A Navarro, Brian H Fasig, Elizabeth W Paxton, Christopher D Grimsrud
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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.</p><p><strong>Questions/purposes: </strong>(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?</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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. 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引用次数: 0

Abstract

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.

在治疗老年股骨颈骨折的无水泥半关节成形术中,不同品牌的股骨柄性能是否存在差异?
背景:与无骨水泥固定相比,有骨水泥股骨固定发生假体周围骨折的风险较低,因此适用于绝大多数老年患者的移位性股骨颈骨折。然而,在美国,无骨水泥固定仍被频繁用于髋部骨折的治疗。因此,了解各个无骨水泥品牌和型号的性能很有帮助。问题/目的:(1) 年龄≥60岁的股骨颈移位骨折患者接受无骨水泥半关节成形术治疗后,不同品牌股骨柄的无菌翻修风险是否存在差异?(2)对于年龄≥60岁、接受无骨水泥半人工关节置换术治疗的股骨颈移位性骨折患者,不同股骨柄品牌的假体周围骨折翻修率是否存在差异?利用凯泽医疗集团(Kaiser Permanente)髋部骨折登记处的数据,进行了一项回顾性、比较性、大数据库队列研究。该综合医疗保健系统覆盖美国 8 个地区的 1200 多万名会员,其会员人数在所服务地区的总人口中具有代表性。髋部骨折登记处收集在该机构内接受髋部骨折修复手术的所有患者的详细资料。然后对这些患者修复后的疗效进行纵向监测,并通过病历审查对所有已确定的疗效进行人工验证。2009年至2021年期间,年龄≥60岁、因股骨颈骨折移位而接受单侧半关节置换术治疗的患者均被识别出来(n = 22248)。排除了因多发性创伤、病理性或开放性骨折而接受半关节成形术的患者,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,以及曾在同一髋部接受过手术的患者(21.4% [4768])。此外,还排除了骨水泥植入手术和植入信息缺失或不一致的手术(例如,使用了骨水泥但记录了无骨水泥植入)(47.1% [10,485])。为了有足够的事件进行评估,研究样本仅限于至少进行过 300 例半关节成形术的七种柄,包括 DePuy Synthes 的四种型号(Corail®、Summit®、Summit Basic 和 Tri-Lock®)和 Zimmer Biomet 的三种型号(Medial-Lateral [M/L] Taper®、Trabecular Metal® 和 Versys® Low Demand Fracture [LD/FX])。最终样本包括 5676 个无骨水泥半关节假体:其中,Corail 653 例、M/L Taper 402 例、Summit 1699 例、Summit Basic 1590 例、Tri-Lock 384 例、Trabecular Metal 637 例和 Versys LD/FX 311 例。手术由 35 家医院的 396 名外科医生完成。组群的平均年龄和体重指数分别为 81 岁和 24 kg/m2;大多数为女性(66% [5676 例中的 3733 例])和白人(79% [5676 例中的 4488 例])。根据标准化的平均差异,我们对七个骨干组的年龄、种族/人种、美国麻醉医师协会(ASA)分类、麻醉技术、手术年份、外科医生半关节置换术的年均手术量和手术年份进行了控制。在5676名患者中,有7%的患者(5676人中有378人)在中位1.6年的会员资格终止后失去了随访机会,56%的患者(5676人中有3194人)在随访期间死亡。采用多变量特定病因 Cox 比例危险度回归模型评估无菌性翻修的风险,并对年龄、性别、ASA 分级、抑郁、手术医生、缺血性贫血、入院到手术的时间以及外科医生年均半关节成形术量进行调整。此外,还加入了随机截距,以消除由同一外科医生实施的半关节置换术的影响。因假体周围骨折而进行翻修的风险也作为次要结果进行了评估:在调整后的分析中,与Summit相比,Summit Basic (HR 1.91 [95% 置信区间 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Versys LD/FX (HR 2.12 [95% CI 1.25 to 3.61]; p = 0.005)在随访期间的无菌翻修风险更高。与Summit相比,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Trabecular Metal(HR 1.14 [95% CI 0.69至1.89];p = 0.61)均无差异。与Summit相比,M/L Taper(HR 2.43 [95% CI 1.29 to 4.58];p = 0.006)和Summit Basic(随访3个月内:HR 1.16 [95% CI 0.60 to 2.25];p = 0.66;随访3个月后:HR 2.84 [95% CI 1.36 to 5.94];p = 0.006)基台因假体周围骨折而翻修的风险更高。
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来源期刊
CiteScore
7.00
自引率
11.90%
发文量
722
审稿时长
2.5 months
期刊介绍: Clinical Orthopaedics and Related Research® is a leading peer-reviewed journal devoted to the dissemination of new and important orthopaedic knowledge. CORR® brings readers the latest clinical and basic research, along with columns, commentaries, and interviews with authors.
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