Optimys 短茎的中期存活率:500 例患者的前瞻性病例系列

Bryan Hamans, S. de Waard, Sjoerd Kaarsemaker, Esther R C Janssen, I. Sierevelt, G. Kerkhoffs, Daniel Haverkamp
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Currently, the long-term survival and functional outcomes of various short stems are still being investigated in different clinics.\n AIM\n To determine the 5-year survival of the Optimys hip stem.\n METHODS\n This was a prospective multicenter cohort study of 500 patients conducted in two hospitals in the Netherlands. All patients received the Optimys short stem (Mathys Ltd, Bettlach, Switzerland). The primary outcome measure was survival of the hip stem, with revision as the endpoint. The secondary outcome measurements included patient-reported outcome measures (PROMs). Kaplan-Meier analysis was used to calculate the 5-year survival rate. Log-minus-log transformation was performed to calculate the 95% confidence interval (95%CI). Mixed model analyses were performed to assess the course of the PROMs during the 1st 2 years after surgery. Analyses were modeled separately for the 1st and 2nd years to calculate the yearly change in PROMs during both follow-up periods with accompanying 95%CIs.\n RESULTS\n The mean age of the total 500 patients was 62.3 years (standard deviation: 10.6) and 202 were male (40%). At a median follow-up of 5.5 years (interquartile range: 4.5-6.7), 7 patients were deceased and 6 revisions were registered, for infection (n = 3), subsidence (n = 2) and malposition (n = 1). This resulted in an overall 5-year survival of 98.8% (95%CI: 97.3-99.5). If infection was left out as reason for revision, a stem survival of 99.4% (95%CI: 98.1-99.8) was seen. Baseline questionnaires were completed by 471 patients (94%), 317 patients (63%) completed the 1-year follow-up questionnaires and 233 patients (47%) completed the 2-year follow-up. Both outcome measures significantly improved across all domains in the 1st year after the operation (P < 0.03 for all domains). 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摘要

背景 近年来,年轻患者接受全髋关节置换术的人数有所增加。与老年人群相比,这一活跃群体对假体的期望值更高,对假体的体力要求也更高。短股骨柄的出现是为了保留近端骨量和关节生物力学,在这一特殊人群中植入短股骨柄变得更为常见。目前,不同诊所仍在研究各种短柄假体的长期存活率和功能效果。目的 确定 Optimys 髋关节柄的 5 年存活率。方法 这是一项前瞻性多中心队列研究,在荷兰两家医院对 500 名患者进行了研究。所有患者都接受了 Optimys 短柄(Mathys 有限公司,瑞士贝特拉赫)。研究的主要结果是髋关节柄的存活率,终点是翻修。次要结果测量包括患者报告的结果测量(PROMs)。Kaplan-Meier分析法用于计算5年存活率。采用对数减对数变换计算95%置信区间(95%CI)。混合模型分析用于评估术后头两年的 PROMs 变化情况。对第 1 年和第 2 年分别进行模型分析,计算出两个随访期 PROMs 的年变化率及相应的 95%CIs 。结果 500 名患者的平均年龄为 62.3 岁(标准差:10.6),其中男性 202 名(占 40%)。中位随访时间为 5.5 年(四分位数间距:4.5-6.7),其中 7 名患者死亡,6 名患者因感染(3 例)、下陷(2 例)和位置不正(1 例)而进行了翻修。因此,5年总存活率为98.8%(95%CI:97.3-99.5)。如果将感染排除在翻修原因之外,则骨干存活率为99.4%(95%CI:98.1-99.8)。471名患者(94%)填写了基线问卷,317名患者(63%)填写了1年随访问卷,233名患者(47%)填写了2年随访问卷。术后第一年,两个结果指标在所有领域都有明显改善(所有领域的 P < 0.03)。术后第 2 年,与 1 年随访相比,各方面均无明显变化。结论 Optimys 干的 5 年存活率为 98.8%。患者报告的结果指标在术后第一年显著增加,并在术后两年的随访中趋于稳定。
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Mid-term survival of the Optimys short stem: A prospective case series of 500 patients
BACKGROUND In recent years, there has been an increase in the number of total hip arthroplasty procedures in the younger patient population. This active group has higher expectations of their prosthesis in comparison to the older population, and there is a greater physical demand for the prosthesis. Short femoral stems were introduced to retain proximal bone stock and joint biomechanics and became more common to implant in this specific population. Currently, the long-term survival and functional outcomes of various short stems are still being investigated in different clinics. AIM To determine the 5-year survival of the Optimys hip stem. METHODS This was a prospective multicenter cohort study of 500 patients conducted in two hospitals in the Netherlands. All patients received the Optimys short stem (Mathys Ltd, Bettlach, Switzerland). The primary outcome measure was survival of the hip stem, with revision as the endpoint. The secondary outcome measurements included patient-reported outcome measures (PROMs). Kaplan-Meier analysis was used to calculate the 5-year survival rate. Log-minus-log transformation was performed to calculate the 95% confidence interval (95%CI). Mixed model analyses were performed to assess the course of the PROMs during the 1st 2 years after surgery. Analyses were modeled separately for the 1st and 2nd years to calculate the yearly change in PROMs during both follow-up periods with accompanying 95%CIs. RESULTS The mean age of the total 500 patients was 62.3 years (standard deviation: 10.6) and 202 were male (40%). At a median follow-up of 5.5 years (interquartile range: 4.5-6.7), 7 patients were deceased and 6 revisions were registered, for infection (n = 3), subsidence (n = 2) and malposition (n = 1). This resulted in an overall 5-year survival of 98.8% (95%CI: 97.3-99.5). If infection was left out as reason for revision, a stem survival of 99.4% (95%CI: 98.1-99.8) was seen. Baseline questionnaires were completed by 471 patients (94%), 317 patients (63%) completed the 1-year follow-up questionnaires and 233 patients (47%) completed the 2-year follow-up. Both outcome measures significantly improved across all domains in the 1st year after the operation (P < 0.03 for all domains). In the 2nd year after surgery, no significant changes were observed in any domain in comparison to the 1-year follow-up. CONCLUSION The Optimys stem has a 5-year survival of 98.8%. Patient-reported outcome measures increased significantly in the 1st postoperative year with stabilization at the 2-year follow-up.
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