哪些术前因素与 THA 后未达到最小临床重要差异有关?一项国际多中心研究的结果。

What Preoperative Factors are Associated With Not Achieving a Minimum Clinically Important Difference After THA? Findings from an International Multicenter Study.

机构信息

P. Rojanasopondist, V. P. Galea , J. W. Connelly , S. J. Matuszak, C. R. Bragdon, H. Malchau, Harris Orthopaedics Laboratory, Massachusetts General Hospital, Boston, MA, USA O. Rolfson, Department of Orthopaedics Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

出版信息

Clin Orthop Relat Res. 2019 Jun;477(6):1301-1312. doi: 10.1097/CORR.0000000000000667.

Abstract

BACKGROUND

Despite innovations in THA, there remains a subgroup of patients who experience only modest pain relief and/or functional improvement after the procedure. Although several studies have previously sought to identify factors before surgery that were associated with achieving or not achieving a meaningful improvement after THA, there is no consensus on which factors are most associated; many studies have relied on single-center or single-country multicenter studies for their cohorts.

QUESTIONS/PURPOSES: We sought to identify (1) the proportion of patients who do not achieve a minimum clinically important difference (MCID) in pain and function 1 year after THA, and (2) the preoperative factors that were associated with not achieving MCIDs in pain and function 1 year after THA.

METHODS

This retrospective study analyzed data gathered from a prospective international, multicenter study examining the long-term clinical outcomes of two different polyethylene liners and two different acetabular shells. A total of 814 patients from 12 centers across four countries were enrolled in the study, with the final cohort consisting of 594 patients (73%) who all had complete preoperative and 1-year PROMs as well as a valid preoperative radiograph used to measure minimum joint space width. The outcomes in this study were achieving evidence-derived MCIDs in (1) pain, defined as a reduction of two points on an 11-point (0 = very little, 10 = worst imaginable) numerical rating scale (NRS) for hip-related pain or reporting a 1 year NRS-pain score of 0, and (2) function, defined as an increase equal to or greater than 8.3 on the SF-36 Physical Function subscore (range: 0 to 100; 0 = maximum disability, 100 = no disability) or reporting a 1-year SF-36 Physical Function subscore within the 95th percentile of scores in our cohort. All demographic variables, such as age, sex, country; surgical factors, including body mass index (BMI), surgical approach, acetabular liner type, and preoperative PROMs, were included as covariates in a binary logistic regression model. We used a backwards stepwise elimination algorithm to reach the simplest, best-fit model.

RESULTS

In the final analysis cohort of 594 patients, 54 patients (9%) did not achieve the MCID in pain and 146 (25%) patients did not achieve the MCID in physical function after THA. After controlling for potential confounding variables such as age, BMI, and preoperative PROMs, we found that higher joint space width (odds ratio (OR) = 2.19; 95% confidence interval (CI) = 1.49-3.22; p < 0.001), lower preoperative SF-36 Mental Component Summary (MCS) (OR = 0.95; 95% CI = 0.93-0.98; p = 0.001), and female sex (OR = 2.04; 95% CI = 1.08-3.82; p = 0.027) were associated with failing to achieve a MCID in pain. It is important to note that the effect size of having a higher preoperative SF-36 MCS is small, with a 1- or 10-point increase in SF-36 MCS decreasing the odds of a patient not achieving the pain MCID by 5% or 63%, respectively.In a separate multivariable model, after controlling for potential confounding variables such as age, BMI, and preoperative PROMs, we found that higher joint space width (OR = 1.54; 95% CI = 1.18-2.02; p = 0.002), higher preoperative Harris hip score (HHS) (OR = 1.01; 95% CI = 1.00-1.03; p = 0.019) and undergoing surgery in Scandinavia (OR = 1.73; 95% CI = 1.17-2.55; p = 0.006) were associated with failing to achieve a MCID in physical function. It is important to note that the effect size of having a higher preoperative HHS is very small, with a 1- or t10-point increase in HHS increasing the odds of not achieving the physical function MCID by only 1% or 15%, respectively.

CONCLUSIONS

These findings suggest that surgeons should counsel patients with high joint space width, female patients, and patients undergoing surgery in Scandinavia that they may be much less likely to experience meaningful pain relief or functional improvement after THA, and in light of that, determine whether indeed surgery should be postponed or avoided in those patients. Lower SF-36 MCS score and higher HHS before surgery were also found to be associated with not achieving MCIDs in pain and physical function, respectively, after surgery, but both had relatively small effect sizes. Future prospective studies may consider exploring the relationship between less pain relief or functional improvement and the risk factors identified in this study, such as high joint space width, to validate our findings and determine if the variables we identified are truly predictive of worse postoperative outcomes. Future retrospective studies of regional or national registry data should use the analysis methods presented within this study to both identify the portion of the THA patients who do not achieve a MCID in pain or physical function after surgery and confirm if the preoperative risk factors for poor improvement identified within our international, multicenter cohort are also found in a larger patient population with more diverse implants and comorbidities.

LEVEL OF EVIDENCE

Level III, therapeutic study.

摘要

背景

尽管全髋关节置换术(THA)领域不断创新,但仍有一部分患者术后仅能获得适度的疼痛缓解和/或功能改善。尽管之前有几项研究试图确定手术前与术后是否能实现有意义的改善相关的因素,但对于哪些因素与改善效果最相关仍存在共识;许多研究依赖于单中心或单一国家的多中心研究队列。

问题/目的:我们旨在确定 (1) 术后 1 年未达到最小临床重要差异(MCID)的患者比例,以及 (2) 与术后 1 年疼痛和功能未达到 MCID 相关的术前因素。

方法

本回顾性研究分析了一项前瞻性国际多中心研究的数据,该研究旨在检查两种不同聚乙烯衬垫和两种不同髋臼壳的长期临床结果。来自四个国家 12 个中心的 814 名患者入组该研究,最终队列包括 594 名患者(73%),他们均具有完整的术前和 1 年患者报告的结局测量(PROMs),以及术前有效放射影像来测量最小关节间隙宽度。本研究的结局为在(1)疼痛和(2)功能方面达到证据衍生的 MCID。疼痛定义为髋关节相关疼痛的数字评分量表(NRS)降低 2 分(0=非常轻微,10=最严重)或报告 1 年 NRS 疼痛评分为 0,功能定义为 SF-36 身体功能子评分增加等于或大于 8.3 分(范围:0 至 100;0=最大残疾,100=无残疾)或报告 1 年 SF-36 身体功能子评分处于我们队列中得分的第 95 百分位数范围内。所有人口统计学变量,如年龄、性别、国家;手术因素,包括体重指数(BMI)、手术入路、髋臼衬垫类型和术前 PROMs,均作为协变量纳入二项逻辑回归模型。我们使用向后逐步消除算法来获得最简单、最佳拟合的模型。

结果

在最终的 594 名患者分析队列中,54 名患者(9%)在术后疼痛方面未达到 MCID,146 名患者(25%)在术后物理功能方面未达到 MCID。在控制年龄、BMI 和术前 PROMs 等潜在混杂变量后,我们发现较高的关节间隙宽度(比值比[OR] = 2.19;95%置信区间[CI] = 1.49-3.22;p<0.001)、较低的术前 SF-36 心理成分综合得分(MCS)(OR = 0.95;95% CI = 0.93-0.98;p = 0.001)和女性性别(OR = 2.04;95% CI = 1.08-3.82;p = 0.027)与未能达到疼痛 MCID 相关。值得注意的是,SF-36 MCS 较高的效应大小较小,SF-36 MCS 增加 1 或 10 分,患者未达到疼痛 MCID 的可能性分别降低 5%或 63%。在一个单独的多变量模型中,在控制年龄、BMI 和术前 PROMs 等潜在混杂变量后,我们发现较高的关节间隙宽度(OR = 1.54;95% CI = 1.18-2.02;p = 0.002)、较高的术前 Harris 髋关节评分(HHS)(OR = 1.01;95% CI = 1.00-1.03;p = 0.019)和在斯堪的纳维亚进行手术(OR = 1.73;95% CI = 1.17-2.55;p = 0.006)与未能达到物理功能 MCID 相关。值得注意的是,HHS 较高的效应大小也非常小,HHS 增加 1 分或 10 分,患者未达到物理功能 MCID 的可能性仅增加 1%或 15%。

结论

这些发现表明,外科医生应该告知关节间隙宽度较高、女性患者和在斯堪的纳维亚进行手术的患者,他们在接受全髋关节置换术后可能不太可能获得有意义的疼痛缓解或功能改善,并且根据这一点,确定是否应该推迟或避免对这些患者进行手术。较低的 SF-36 MCS 得分和较高的 HHS 术前得分也分别与术后疼痛和功能未达到 MCID 相关,但两者的效应大小都较小。未来的前瞻性研究可能会考虑探讨疼痛缓解或功能改善程度较低与本研究中确定的风险因素之间的关系,例如关节间隙宽度较高,以验证我们的发现,并确定我们确定的变量是否确实预测了术后结局较差。未来对区域或国家登记数据的回顾性研究应使用本研究中提出的分析方法,不仅确定术后未达到 MCID 的 THA 患者比例,而且确认我们在国际多中心队列中发现的改善不良的术前危险因素是否也存在于具有更多样化植入物和合并症的更大患者人群中。

证据水平

III 级,治疗性研究。

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