S.-H. Won, Y.-K. Lee, K.-H. Koo, Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Seongnam, South Korea.
J.-W. Park, Y.-C. Ha, Department of Orthopaedic Surgery, Chung-Ang University College of Medicine, Seoul, South Korea.
Clin Orthop Relat Res. 2021 Apr 1;479(4):767-777. doi: 10.1097/CORR.0000000000001505.
Short-length stems were developed to reduce bone loss of the proximal femur and potentially decrease the incidence of thigh pain after cementless THA. However, it remains unknown whether short stems indeed reduce bone loss or the frequency of thigh pain.
QUESTIONS/PURPOSES: Is there a difference between short- and standard-length stems in terms of: (1) the frequency or severity of thigh pain, (2) modified Harris hip scores, (3) implant loosening, or (4) bone mineral density as measured by dual-energy x-ray absorptiometry?
Between March 2013 and January 2014, three surgeons performed 205 primary THAs. To be eligible, patients needed to be at least 20 years of age, have not undergone previous history of hip surgery, and have no metabolic bone disease. A total of 100 patients were randomized to receive THA either with a short stem (n = 56) or with a standard-length stem (n = 44). Both stems were proximally coated, tapered, cementless stems. Compared with standard stems, short stems typically were 30- to 35-mm shorter. A total of 73% (41 of 56) and 77% (34 of 44) of those groups, respectively, were accounted for at a minimum of 5 years and were analyzed. The presence of thigh pain during activity was evaluated using a 10-point VAS, and the modified Harris hip score was calculated by research assistants who were blinded to the treatment groups. Plain radiographs were taken at 6 weeks, 6 months, and 12 months postoperatively, and every 1 year thereafter; loosening was defined as subsidence > 3 mm or a position change > 3° on serial radiographs. Radiological assessment was performed by two researchers who did not participate in the surgery and follow-up evaluations. Bone mineral density of the proximal femur was measured using dual-energy x-ray absorptiometry at 4 days, 1 year, 2 years, and 5 years postoperatively. The primary endpoint of our study was the incidence of thigh pain during 5-year follow-up. Our study was powered at 80% to detect a 10% difference in the proportion of patients reporting thigh pain at the level of 0.05.
With the numbers available, we found no difference between the groups in the proportion of patients with thigh pain; 16% (9 of 56) of patients in the short-stem group and 14% (6 of 44) of patients in the standard-stem group experienced thigh pain during the follow-up period (p = 0.79). In all patients, the pain was mild or moderate (VAS score of 4 or 6 points). Among the 15 available patients who reported thigh pain, there was no difference between the implant groups in mean severity of thigh pain (4.3 ± 0.8 versus 4.2 ± 0.7; p = 0.78). There were no between-group differences in the short versus standard-length stem groups in terms of mean modified Harris hip score by 5 years after surgery (89 ± 13 versus 95 ± 7 points; p = 0.06). No implant was loose and no hip underwent revision in either group. Patients in the short-stem group showed a slightly smaller decrease in bone mineral density in Gruen Zones 2, 3, and 5 than those in the standard-stem group did; the magnitude of the difference seems unlikely to be clinically important.
We found no clinically important differences (and few differences overall) between short and standard-length THA stems 5 years after surgery in a randomized trial. Consequently, we recommend that clinicians use standard-length stems in general practice because standard-length stems have a much longer published track record in other studies, and short stems can expose patients to the uncertainty associated with novelty, without any apparent offsetting benefit.
Level I, therapeutic study.
短柄的研发旨在减少股骨近端的骨质丢失,并可能降低非骨水泥全髋关节置换术后大腿疼痛的发生率。然而,短柄是否确实能减少骨质丢失或大腿疼痛的频率,目前仍不清楚。
问题/目的:在以下方面,短柄和标准柄之间是否存在差异:(1)大腿疼痛的频率或严重程度,(2)改良 Harris 髋关节评分,(3)假体松动,或(4)双能 X 线吸收法测量的骨密度?
2013 年 3 月至 2014 年 1 月,三位外科医生进行了 205 例初次全髋关节置换术。符合条件的患者需要至少 20 岁,无髋关节手术史,无代谢性骨病。共有 100 例患者随机分为接受短柄(n=56)或标准柄(n=44)的全髋关节置换术。两种柄均为近端涂层、锥形、非骨水泥柄。与标准柄相比,短柄通常短 30-35mm。分别有 73%(56 例中的 41 例)和 77%(44 例中的 34 例)的患者分别在至少 5 年后进行了分析。使用 10 分视觉模拟量表(VAS)评估活动时大腿疼痛的情况,改良 Harris 髋关节评分由研究助理计算,研究助理对治疗组不知情。术后 6 周、6 个月和 12 个月以及此后每年拍摄平片;松动定义为沉降>3mm 或连续影像学上位置变化>3°。由未参与手术和随访评估的两位研究人员进行放射学评估。使用双能 X 线吸收法在术后 4 天、1 年、2 年和 5 年测量股骨近端骨密度。本研究的主要终点是在 5 年随访期间大腿疼痛的发生率。我们的研究在 80%的水平上有能力检测到报告大腿疼痛的患者比例有 10%的差异,差异水平为 0.05。
根据现有的数据,我们发现两组之间大腿疼痛的患者比例没有差异;短柄组有 16%(56 例中的 9 例)和标准柄组有 14%(44 例中的 6 例)的患者在随访期间出现大腿疼痛(p=0.79)。在所有患者中,疼痛均为轻度或中度(VAS 评分为 4 或 6 分)。在报告大腿疼痛的 15 名可用患者中,两组之间的疼痛严重程度没有差异(平均 4.3±0.8 与 4.2±0.7;p=0.78)。在术后 5 年,短柄组与标准柄组在改良 Harris 髋关节评分方面没有差异(89±13 与 95±7 分;p=0.06)。两组均无假体松动和髋关节翻修。短柄组患者的股骨近端 Gruen 区 2、3 和 5 的骨密度下降略小于标准柄组;这种差异的幅度似乎不太可能具有临床意义。
在一项随机试验中,我们发现短柄和标准柄在全髋关节置换术后 5 年时没有明显的临床差异(总体差异较小)。因此,我们建议临床医生在常规实践中使用标准柄,因为标准柄在其他研究中有更长的发表记录,而短柄可能会使患者面临与新颖性相关的不确定性,而没有任何明显的优势。
I 级,治疗性研究。