Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Japan.
Department of Rehabilitation, Hokusuikai Kinen Hospital, Mito, Japan.
Clin Orthop Relat Res. 2023 Aug 1;481(8):1515-1523. doi: 10.1097/CORR.0000000000002602. Epub 2023 Mar 2.
Previous studies reported good outcomes of acetabular cup placement using portable navigation systems during THA. However, we are aware of no prospective studies comparing inexpensive portable navigation systems using augmented reality (AR) technology with accelerometer-based portable navigation systems in THA.
QUESTIONS/PURPOSES: (1) Is the placement accuracy of the acetabular cup using the AR-based portable navigation system superior to that of an accelerometer-based portable navigation system? (2) Do the frequencies of surgical complications differ between the two groups?
We conducted a prospective, two-arm, parallel-group, randomized controlled trial involving patients scheduled for unilateral THA. Between August and December 2021, we treated 148 patients who had a diagnosis of osteoarthritis, idiopathic osteonecrosis, rheumatoid arthritis, or femoral neck fracture and were scheduled to undergo unilateral primary THA. Of these patients, 100% (148) were eligible, 90% (133) were approached for inclusion in the study, and 85% (126) were finally randomized into either the AR group (62 patients) or the accelerometer group (64 patients). An intention-to-treat analysis was performed, and there was no crossover between groups and no dropouts; all patients in both groups were included in the analysis. There were no differences in any key covariates, including age, sex, and BMI, between the two groups. All THAs were performed via the modified Watson-Jones approach with the patient in the lateral decubitus position. The primary outcome was the absolute difference between the cup placement angle displayed on the screen of the navigation system and that measured on postoperative radiographs. The secondary outcome was intraoperative or postoperative complications recorded during the study period for the two portable navigation systems.
There were no differences between the AR and accelerometer groups in terms of the mean absolute difference in radiographic inclination angle (3° ± 2° versus 3° ± 2° [95% CI -1.2° to 0.3°]; p = 0.22). The mean absolute difference in radiographic anteversion angle displayed on the navigation screen during surgery compared with that measured on postoperative radiographs was smaller in the AR group than that in the accelerometer group (2° ± 2° versus 5° ± 4° [95% CI -4.2° to -2.0°]; p < 0.001). There were few complications in either group. In the AR group, there was one patient each with a surgical site infection, intraoperative fracture, distal deep vein thrombosis, and intraoperative pin loosening; in the accelerometer group, there was one patient each with an intraoperative fracture and intraoperative loosening of pins.
Although the AR-based portable navigation system demonstrated slight improvements in radiographic anteversion of cup placement compared with the accelerometer-based portable navigation system in THA, whether those small differences will prove clinically important is unknown. Until or unless future studies demonstrate clinical advantages that patients can perceive that are associated with such small radiographic differences, because of the costs and the unquantified risks associated with novel devices, we recommend against the widespread use of these systems in clinical practice.
Level I, therapeutic study.
先前的研究报告称，在全髋关节置换术中使用便携式导航系统可获得良好的髋臼杯放置效果。然而，我们尚未发现有前瞻性研究比较使用基于增强现实（AR）技术的廉价便携式导航系统与基于加速度计的便携式导航系统在全髋关节置换术中的应用。
问题/目的：（1）基于 AR 的便携式导航系统的髋臼杯放置准确性是否优于基于加速度计的便携式导航系统？（2）两组的手术并发症发生率是否存在差异？
我们进行了一项前瞻性、双臂、平行组、随机对照试验，纳入了计划行单侧全髋关节置换术的患者。在 2021 年 8 月至 12 月期间，我们治疗了 148 名患有骨关节炎、特发性股骨头坏死、类风湿性关节炎或股骨颈骨折并计划行单侧初次全髋关节置换术的患者。这些患者中，100%（148 名）符合条件，90%（133 名）被邀请入组，最终 85%（126 名）被随机分为 AR 组（62 名患者）或加速度计组（64 名患者）。采用意向治疗分析，两组之间无交叉，无脱落；两组所有患者均纳入分析。两组间的关键协变量，包括年龄、性别和 BMI，均无差异。所有全髋关节置换术均采用改良的 Watson-Jones 入路，患者取侧卧位。主要结局是导航系统屏幕上显示的髋臼杯放置角度与术后 X 线片上测量的角度之间的绝对差值。次要结局是研究期间两种便携式导航系统记录的术中或术后并发症。
在术后 X 线片倾斜角的平均绝对差值方面，AR 组与加速度计组之间无差异（3°±2°与 3°±2°[95%CI-1.2°至 0.3°]；p=0.22）。与术后 X 线片相比，手术过程中导航屏幕上显示的髋臼杯前倾角的平均绝对差值在 AR 组较小，而在加速度计组较大（2°±2°与 5°±4°[95%CI-4.2°至-2.0°]；p<0.001）。两组并发症均较少。AR 组各有 1 例患者发生手术部位感染、术中骨折、远端深静脉血栓形成和术中钢针松动；加速度计组各有 1 例患者发生术中骨折和术中钢针松动。
尽管基于 AR 的便携式导航系统在全髋关节置换术中与基于加速度计的便携式导航系统相比，在髋臼杯放置的 X 线前倾角方面略有改善，但这些小差异是否具有临床重要性尚不清楚。在未来的研究证明这些小的 X 线差异与患者可感知的临床优势相关，并与这些系统相关的成本和未量化的风险相关联之前，我们建议不要在临床实践中广泛使用这些系统。
I 级，治疗性研究。
