Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA; Department of Orthopaedics and Sports Medicine, University of Washington, Seattle, WA, USA.
Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA.
J Shoulder Elbow Surg. 2024 Feb;33(2):223-233. doi: 10.1016/j.jse.2023.08.014. Epub 2023 Sep 27.
Traditional, commercially sourced patient-specific instrumentation (PSI) systems for shoulder arthroplasty improve glenoid component placement but can involve considerable cost and outsourcing delays. The purpose of this randomized controlled trial was to compare the accuracy of glenoid component positioning in anatomic total shoulder arthroplasty (aTSA) using an in-house, point-of-care, 3-dimensionally (3D) printed patient-specific glenoid drill guide vs. standard nonspecific instrumentation.
This single-center randomized controlled trial included 36 adult patients undergoing primary aTSA. Patients were blinded and randomized 1:1 to either the PSI or the standard aTSA guide groups. The primary endpoint was the accuracy of glenoid component placement (version and inclination), which was determined using a metal-suppression computed tomography scan taken between 6 weeks and 1 year postoperatively. Deviation from the preoperative 3D templating plan was calculated for each patient. Blinded postoperative computed tomography measurements were performed by a fellowship-trained shoulder surgeon and a musculoskeletal radiologist.
Nineteen patients were randomized to the patient-specific glenoid drill guide group, and 17 patients were allocated to the standard instrumentation control group. There were no significant differences between the 2 groups for native version (P = .527) or inclination (P = .415). The version correction was similar between the 2 groups (P = .551), and the PSI group was significantly more accurate when correcting version than the control group (P = .042). The PSI group required a significantly greater inclination correction than the control group (P = .002); however, the 2 groups still had similar accuracy when correcting inclination (P = .851). For the PSI group, there was no correlation between the accuracy of component placement and native version, native inclination, or the Walch classification of glenoid wear (P > .05). For the control group, accuracy when correcting version was inversely correlated with native version (P = .033), but accuracy was not correlated with native inclination or the Walch classification of glenoid wear (P > .05). The intraclass correlation coefficient was 0.703 and 0.848 when measuring version and inclination accuracy, respectively.
When compared with standard instrumentation, the use of in-house, 3D printed, patient-specific glenoid drill guides during aTSA led to more accurate glenoid component version correction and similarly accurate inclination correction. Additional research should examine the influence of proper component position and use of PSI on clinical outcomes.
传统的、商业化来源的用于肩关节置换的患者特异性仪器（PSI）系统可以改善肩胛盂部件的位置，但可能涉及相当大的成本和外包延迟。本随机对照试验的目的是比较使用内部、即时、三维（3D）打印的患者特异性肩胛盂钻头导向器与标准非特异性仪器在解剖型全肩关节置换（aTSA）中肩胛盂部件定位的准确性。
本单中心随机对照试验纳入了 36 例接受初次 aTSA 的成年患者。患者采用盲法和 1:1 随机分组至 PSI 或标准 aTSA 引导组。主要终点是肩胛盂部件位置（位置和倾斜度）的准确性，这是通过术后 6 周到 1 年之间进行的金属抑制计算机断层扫描（CT）扫描来确定的。计算了每位患者与术前 3D 模板计划的偏差。由一名肩部关节镜 fellowship培训的外科医生和一名肌肉骨骼放射科医生进行术后 CT 盲法测量。
19 例患者被随机分配至患者特异性肩胛盂钻头导向器组，17 例患者被分配至标准仪器对照组。两组之间的原始版本（P =.527）或倾斜度（P =.415）没有显著差异。两组之间的版本校正相似（P =.551），PSI 组在纠正版本方面明显比对照组更准确（P =.042）。PSI 组需要比对照组更大的倾斜度校正（P =.002）；然而，两组在纠正倾斜度时仍然具有相似的准确性（P =.851）。对于 PSI 组，组件位置的准确性与原始版本、原始倾斜度或肩胛盂磨损的 Walch 分类之间没有相关性（P ＞.05）。对于对照组，校正版本的准确性与原始版本呈负相关（P =.033），但与原始倾斜度或肩胛盂磨损的 Walch 分类无关（P ＞.05）。测量版本和倾斜度准确性的组内相关系数分别为 0.703 和 0.848。
与标准仪器相比，在 aTSA 中使用内部、3D 打印的、患者特异性肩胛盂钻头导向器可实现更准确的肩胛盂部件位置校正和类似的倾斜度校正。应进一步研究适当的组件位置和 PSI 的使用对临床结果的影响。
