Department of Orthopaedic Surgery, Tufts Medical Center, Boston, MA, USA.
Division of Sports Medicine & Shoulder, Department of Orthopedics, Midwest Orthopedics at Rush, Rush University, Chicago, IL, USA.
J Shoulder Elbow Surg. 2021 Nov;30(11):2523-2532. doi: 10.1016/j.jse.2021.02.015. Epub 2021 Mar 9.
Clinically significant outcome (CSO) benchmarks have been previously established for outcome assessment after total shoulder arthroplasty. However, the time required to achieve CSO improvement is not well understood. The purpose of this study was to (1) determine the time-dependent achievement of the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptom state (PASS) in patients undergoing either anatomic total shoulder (TSA) or reverse total shoulder arthroplasty (RTSA) and compare the results of the 2 populations and (2) identify variables associated with earlier or delayed achievement of each CSO.
A prospectively maintained institutional registry was retrospectively queried for all patients receiving a primary TSA or RTSA between September 2, 2016-October 31, 2017. The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) was administered to all patients preoperatively and at standardized postoperative time periods: 5-7 months (6-month time point), 11-13 months (1-year time point), and 23-25 months (2-year time point). Cumulative percentages of CSO achievement were calculated using Kaplan-Meier survival curve analysis with interval censoring. A Weibull parametric survival regression analysis was used to investigate the influence of demographic and clinical variables on delayed or earlier CSO achievement.
A total of 153 patients (157 shoulders) undergoing TSA (n = 76) and RTSA (n = 81) were included in the study population. The RTSA cohort was older (70.2 ± 7.5 vs. 61.0 ± 8.4, P < .001), had a lower BMI (28.8 ± 5.9 vs. 31.5 ± 6.5, P = .006), and a greater proportion of females (53.1% vs. 32.9%, P = .017) relative to TSA. For SCB, there was a significant difference in the cumulative percentage of TSA and RTSA patients reaching this threshold at both the 6-month (77.3% vs. 59.0%, P = .024) and 2-year (92.0% vs. 79.5%, P = .048) time periods, with similar findings demonstrated for PASS. There was a significant difference in the average time required to achieve the PASS (TSA: 6.1 months vs. rTSA: 11.6 months, P = .009), but not the MCID (P = .407) or SCB (P = .153). Factors significantly associated with earlier achievement of more than 1 of the CSO benchmarks were regular preoperative physical exercise and diagnosis of rotator cuff tear without osteoarthritis.
Patients undergoing RTSA had lower rates of achieving SCB and PASS at both 6 months and 2 years compared to patients undergoing TSA. Patients undergoing RTSA on average required nearly double the time to achieve PASS compared with those undergoing TSA. In both groups, clinically significant improvement continued for the entire 2-year duration of study follow-up.
临床上有意义的结果 (CSO) 基准先前已在全肩关节置换术后的结果评估中建立。然而,达到 CSO 改善所需的时间尚不清楚。本研究的目的是:(1) 确定接受解剖型全肩关节 (TSA) 或反式全肩关节置换术 (RTSA) 的患者在时间依赖性上达到最小临床重要差异 (MCID)、实质性临床获益 (SCB) 和患者可接受的症状状态 (PASS) 的情况,并比较这两种人群的结果;(2) 确定与每个 CSO 更早或更晚实现相关的变量。
对 2016 年 9 月 2 日至 2017 年 10 月 31 日期间接受初次 TSA 或 RTSA 的所有患者,从一个前瞻性维护的机构登记处进行回顾性查询。所有患者在术前和标准化的术后时间点接受美国肩肘外科医师协会 (ASES) 标准肩部评估表 (ASES) 评估:5-7 个月 (6 个月时间点)、11-13 个月 (1 年时间点) 和 23-25 个月 (2 年时间点)。使用 Kaplan-Meier 生存曲线分析和区间 censoring 计算 CSO 实现的累积百分比。使用 Weibull 参数生存回归分析研究人口统计学和临床变量对 CSO 更早或更晚实现的影响。
共纳入研究人群 153 例(157 肩)接受 TSA(n = 76)和 RTSA(n = 81)。RTSA 队列年龄更大(70.2 ± 7.5 岁 vs. 61.0 ± 8.4 岁,P <.001),BMI 更低(28.8 ± 5.9 公斤/平方米 vs. 31.5 ± 6.5 公斤/平方米,P =.006),女性比例更高(53.1% vs. 32.9%,P =.017)。在 SCB 方面,在 6 个月 (77.3% vs. 59.0%,P =.024)和 2 年 (92.0% vs. 79.5%,P =.048)时间点,TSA 和 RTSA 患者达到这一阈值的累积百分比存在显著差异,而 PASS 的结果相似。达到 PASS 的平均时间存在显著差异(TSA:6.1 个月 vs. rTSA:11.6 个月,P =.009),但 MCID(P =.407)或 SCB(P =.153)无差异。与达到多个 CSO 基准的时间更早显著相关的因素是术前定期进行体育锻炼和诊断为肩袖撕裂而无骨关节炎。
与 TSA 患者相比,接受 RTSA 的患者在 6 个月和 2 年时的 SCB 和 PASS 发生率较低。接受 RTSA 的患者平均需要近两倍的时间才能达到 PASS,而接受 TSA 的患者则不需要。在这两组患者中,在整个 2 年的研究随访期间,临床上有意义的改善仍在继续。