背景:已经研究了使用3D打印的患者专用仪器(PSI)来增强全髋关节置换术(THA)的术后功能结果,并且已被认为是最佳排列的创新方法髋关节植入物组件。即时生产正逐渐成为PSI制造的常态。本文的目的是评估PSI在越南医疗点进行的全髋关节置换术的准确性和安全性。
方法:本前瞻性研究评估了34例THA病例。使用来自下肢的术前3D计算机断层扫描(CT)扫描的数据生成植入物的大小和方向以及PSI设计的模板。主要外科医生使用该软件直接确定植入物的位置和PSI设计。然后在我们的制造医院使用3D兼容的树脂打印机生产PSI。PSI,由压配合在骨表面上的髋臼和股骨部件组成,指导外科医生根据预先计划的平面精确地扩孔髋臼并切割股骨颈。获得术后CT扫描,并将其叠加到植入物的3D模型上,以通过比较杯子的取向值和计划结果与实际结果之间的茎对齐来评估手术的准确性。手术的术中和术后临床参数,包括手术时间,术中失血,并发症,第一次行走,还记录了手术的安全性。
结果:制备PSI平均需要3天。正确选择了94%的杯尺寸和91%的茎尺寸。术后前倾和前倾的平均值分别为44.2°±4.1°和19.2°±5.6°,分别。64.7%的病例在±50范围内偏离计划,94.1%在±10°范围内偏离计划。茎前倾的计划值与实现值无显著统计学差异,截骨高度,和腿长差异(p>0.05)。平均手术时间82.5°±10.8min,术中失血量估计为317.7°±57.6ml。64.7%的患者在手术当天可以行走。无并发症报告。
结论:现场护理制造的PSI是提高全髋关节置换术准确性的有用解决方案,特别是在恢复植入物的方向和减少腿长度差异。然而,需要进行长期临床随访评估以确认该方法的有效性和安全性.
BACKGROUND: The use of 3D-printed Patient-Specific Instruments (
PSI) has been investigated to enhance the postoperative functional results in total hip arthroplasty (THA) and has been recognized as an innovative approach for the optimal alignment of hip implant components. Point-of-care production is gradually becoming the norm for
PSI manufacturing. The purpose of this article is to assess the accuracy and safety of PSI for total hip arthroplasty performed at the point-of-care in Vietnam.
METHODS: 34 THA cases were assessed in this prospective study. A template for the size and orientation of the implant and the design of the
PSI was generated using data from preoperative 3D computed tomography (CT) scanning of the lower limb. The principal surgeon determined the implants\' position and
PSI design directly using the software. The
PSI is then produced using a 3D-compatible resin printer in our manufacturing hospital. The PSI, consisting of an acetabulum and a femoral component placed press-fit on the bony surface, guided surgeons to precisely ream the acetabulum and cut the femoral neck according to the pre-planned plane. Postoperative CT scanning was obtained and superimposed onto the 3D model of the implant to evaluate the accuracy of the procedure by comparing the orientation values of the cup and the alignment of the stem between the planned and the actual results. Intra- and postoperative clinical parameters of surgery, including surgical time, intra-operative blood loss, complications, and the first ambulation, were also recorded to evaluate the safety of the surgery.
RESULTS: The preparation for PSI required an average of 3 days. 94% of cup size and 91% of stem size were correctly selected. The mean values of postoperative inclination and anteversion were 44.2° ± 4.1° and 19.2° ± 5.6°, respectively. 64.7% of cases deviated from planned within the ± 50 range and 94.1% within the ± 10° range. There was no significant statistical difference between the planned and the achieved values of stem anteversion, osteotomy height, and leg length discrepancy (p > 0.05). The average surgical time was 82.5° ± 10.8 min, and the intraoperative blood loss was estimated at 317.7° ± 57.6 ml. 64.7% of patients could walk on the day of surgery. There were no complications reported.
CONCLUSIONS: The point-of-care manufactured PSI is a useful solution for improving the accuracy of total hip arthroplasty surgery, especially in restoring implant orientation and reducing leg length discrepancy. However, long-term clinical follow-up evaluation is needed to confirm the efficacy and safety of this approach.