E. Bülow, S. Nemes, O. Rolfson, The Swedish Hip Arthroplasty Register, Center of Registers, Västra Götaland, Sweden.
E. Bülow, S. Nemes, O. Rolfson, Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.
Clin Orthop Relat Res. 2020 Jun;478(6):1262-1270. doi: 10.1097/CORR.0000000000001210.
Bilateral THAs performed in the same patient should not be considered independent observations, neither biologically nor statistically. As a result, when surgical results are reviewed, it is common to analyze only the first of the two hips, assuming that the first, and not the second hip of a staged bilateral THA, better resembles unilateral THAs. This assumption has not been empirically justified.Question/purposes (1) In patients with staged bilateral THA, is the first or second hip more similar to a unilateral THA in terms of age at surgery, presence of any preoperative Charlson comorbidity, and risk of postoperative reoperation? (2) Should the date of a first or second hip surgery of a staged bilateral THA be used as a starting point for patient survival to better resemble patients with unilateral THA?
We identified 68,357 THAs due to osteoarthritis in 63,613 patients from the Swedish Hip Arthroplasty Register (SHAR) in 1999-2015. Of those THAs, 14,780 concerned the first hip of a staged bilateral procedure performed between 1999 and 2004; 28,542 were unilaterals from 2004 to 2008, and 25,035 concerned the second hip of a staged bilateral procedure performed 2008 to 2015. We excluded patients who underwent one-stage bilateral THAs. We used different inclusion periods to distinguish unilateral procedures from the first and second hips from staged bilateral procedures because sufficiently long set-up and follow-up periods were needed before and after each period to identify possible contralateral THAs. This introduced potential period confounding, meaning that possible group differences might not be distinguished from unrelated outcome differences over time. We investigated if such time trends existed. It did not for age and reoperation rates, but it did for comorbidity and patient survival. Our primary study endpoint was whether patients with unilateral THAs were more similar to patients with a first hip of a staged bilateral THA, or to patients with their second hip operated. We used Student's t-test to compare mean age at surgery. The proportion of patients with at least one presurgery Charlson comorbidity were compared by 95% bootstrap confidence intervals, after subtracting the yearly time-trend to avoid period confounding. Postoperative risks of reoperation were compared by log-rank tests of Kaplan-Meier curves and by comparing 5-year reoperation rates by pair-wise 95% CIs. Our secondary study endpoint was to compare patient survival for patients with a unilateral THA, a first hip of a staged bilateral THA, or a second hip of a staged bilateral THA. We evaluated this by relative 5-year survival, comparing patients of each group with the general Swedish population of the same age, sex, and year of birth. This way, possible survival differences would be less likely explained by period confounding.
Patients undergoing unilateral THA were older than those undergoing a first hip of a staged bilateral THA (70 ± 10 versus 66 ± 9 years, mean difference of 4; p < .001), but they were not different from patients undergoing the second hip of a staged bilateral THA (70 ± 9 years, mean difference of 0; p = 0.74). The period-adjusted proportion of patients with unilateral THA and presurgery comorbidity (Charlson index > 0) was 20% (95% CI: 19.8-20.7). This was no different from patients with a second hip from a staged bilateral THA (20%; 19.7-20.6), but higher compared to patients with a first hip of a staged bilateral THA (15%; 14.5-15.4). For reoperation rates, the log-rank tests showed no difference between unilateral THAs and the second hips of staged bilateral THAs ((Equation is included in full-text article.)). Such difference was found for unilaterals compared with the first hips of staged bilateral THAs ((Equation is included in full-text article.)). The Kaplan-Meier estimate of reoperation rates at 5 years after surgery were also no different for the unilateral THAs compared with the second hips of staged bilateral THAs (3% [95% CI 2.8 to 3.2] for both groups). It was lower (2% [95% CI 1.8 to 2.3]) for a first hip of a staged bilateral THA. For the secondary outcome, the relative 5-year survival differed for all groups. It was 105% (95% CI 104.9 to 105.9) for patients with unilateral THA, 107% (95% CI 106.3 to 107.4) for patients with a second hip from a staged bilateral THA and 109% (95% CI 108.8 to 109.5) for patients with a first hip of a staged bilateral THA. Patients with only a first hip of a planned staged bilateral THA who did not survive long enough to undergo their second THA were classified as unilaterals. The rank-order of survival curves are therefore by design ("immortal time bias"). We conclude, however, that survival for patients with unilateral THA more closely resembles the survival of patients with a second hip of a staged bilateral THA, compared with the first.
Our findings, which are based on observational register data, challenge the common practice in epidemiologic studies of analyzing only the first hip of a staged bilateral THA. We recommend analyzing the second THA in a patient who has undergone staged bilateral THA rather than the first because the second procedure better resembles unilateral THA.
Level III, therapeutic study.
在同一位患者中进行双侧全髋关节置换术不应被视为生物学或统计学上的独立观察结果。因此,在审查手术结果时,通常只分析两次髋关节置换术的第一次,假设第一次髋关节置换术( staged bilateral THA 的第一髋)比第二次髋关节置换术( staged bilateral THA 的第二髋)更类似于单侧全髋关节置换术。但这种假设尚未得到经验验证。
问题/目的:(1) 在分期双侧全髋关节置换术的患者中,就手术时的年龄、是否存在任何术前 Charlson 合并症以及术后再次手术的风险而言,第一髋或第二髋与单侧全髋关节置换术更相似?(2) 分期双侧全髋关节置换术的第一髋或第二髋手术日期是否应作为患者生存的起始点,以更好地与单侧全髋关节置换术患者相似?
我们从 1999 年至 2015 年瑞典髋关节置换登记处(SHAR)中确定了 63613 名患者的 68357 例因骨关节炎而进行的全髋关节置换术。这些全髋关节置换术中,14780 例涉及 1999 年至 2004 年分期双侧手术的第一髋;28542 例为 2004 年至 2008 年的单侧手术,25035 例涉及 2008 年至 2015 年分期双侧手术的第二髋。我们排除了接受一期双侧全髋关节置换术的患者。我们使用不同的纳入期来区分单侧手术和分期双侧手术的第一和第二髋,因为在每个时期之前和之后都需要足够长的设定和随访期来识别可能的对侧全髋关节置换术。这引入了潜在的时期混杂,这意味着可能的组间差异可能无法与随时间推移的无关结果差异区分开来。我们调查了是否存在这种时间趋势。对于年龄和再手术率来说并非如此,但对于合并症和患者生存率来说确实如此。我们的主要研究终点是单侧全髋关节置换术患者是否更类似于分期双侧全髋关节置换术的第一髋患者,或更类似于分期双侧全髋关节置换术的第二髋患者。我们使用学生 t 检验比较手术时的平均年龄。使用 95%的 bootstrap 置信区间比较至少有一个术前 Charlson 合并症的患者比例,减去每年的时间趋势以避免时期混杂。通过 Kaplan-Meier 曲线的对数秩检验和通过逐个比较 5 年再手术率的 95%置信区间比较术后再手术风险。我们的次要研究终点是比较单侧全髋关节置换术、分期双侧全髋关节置换术的第一髋或第二髋患者的患者生存率。我们通过比较每组患者与同年龄、性别和出生年份的瑞典一般人群的相对 5 年生存率来评估这一点。这样,可能的生存差异就不太可能因时期混杂而得到解释。
接受单侧全髋关节置换术的患者比接受分期双侧全髋关节置换术的第一髋患者年龄更大(70 ± 10 岁比 66 ± 9 岁,平均差异 4;p <.001),但与接受分期双侧全髋关节置换术的第二髋患者无差异(70 ± 9 岁,平均差异 0;p = 0.74)。单侧全髋关节置换术和术前 Charlson 指数>0 的患者中,有 20%(95%CI:19.8-20.7)存在合并症。这与分期双侧全髋关节置换术的第二髋患者(20%;19.7-20.6)没有不同,但高于分期双侧全髋关节置换术的第一髋患者(15%;14.5-15.4)。对于再手术率,对数秩检验显示单侧全髋关节置换术与分期双侧全髋关节置换术的第二髋之间无差异((Equation is included in full-text article.))。而单侧全髋关节置换术与分期双侧全髋关节置换术的第一髋之间存在差异((Equation is included in full-text article.))。手术后 5 年的 Kaplan-Meier 估计再手术率也无差异(两组均为 3%[95%CI 2.8-3.2])。分期双侧全髋关节置换术的第一髋的再手术率较低(2%[95%CI 1.8-2.3])。对于次要结果,所有组别的相对 5 年生存率均不同。单侧全髋关节置换术患者为 105%(95%CI 104.9-105.9),分期双侧全髋关节置换术的第二髋患者为 107%(95%CI 106.3-107.4),分期双侧全髋关节置换术的第一髋患者为 109%(95%CI 108.8-109.5)。仅接受分期双侧全髋关节置换术的第一髋但未存活足够长的时间进行第二次全髋关节置换术的患者被归类为单侧患者。因此,生存曲线的排序顺序是设计的(“不朽时间偏倚”)。然而,我们的结论是,与分期双侧全髋关节置换术的第一髋相比,单侧全髋关节置换术患者的生存率更接近分期双侧全髋关节置换术的第二髋患者的生存率。
我们基于观察性登记数据的发现挑战了在流行病学研究中仅分析分期双侧全髋关节置换术的第一髋的常见做法。我们建议分析接受分期双侧全髋关节置换术的患者的第二次髋关节置换术,而不是第一次,因为第二次手术更类似于单侧全髋关节置换术。
III 级,治疗性研究。