Boyle Richard, Scholes Corey, Franks Daniel, Lodhia Amish, Harrison-Brown Meredith, Ebrahimi Milad, Guzman Maurice, Stalley Paul
Sydney University, Camperdown, Australia.
Royal Prince Alfred Hospital, Camperdown, Australia.
Arch Orthop Trauma Surg. 2025 Aug 28;145(1):431. doi: 10.1007/s00402-025-06008-2.
Access to custom 3D printed pelvic implants (3DPI) is improving for application in both arthroplasty revision and tumour reconstruction. There is limited evidence regarding the safety and outcomes of such implants for large bony defects of the pelvis. The aim of this study is to report the incidence of complications, patient mortality and implant survival following pelvic reconstruction using custom 3Dprinted prostheses in the setting of extensive pelvic bone defects following pelvic tumour resection or failure of total hip arthroplasty (THA).
Patients who underwent reconstruction with a custom 3D printed pelvic prosthesis (3DPI) were identified from our clinical outcomes registry (Complex Reconstruction and Sarcoma Surgical Outcomes Registry; ANZCTRN 12621001421820). Indications for surgery, adverse events, reoperations and rates and modes of failure were recorded. Kaplan-Meier and multistate survival curves were generated for cumulative survival based on indication.
One hundred and six procedures were completed (Revision THA = 33; Tumour Pelvis = 73) with a median follow up of 4.1 years, ranging from 0.6 to 10 years. Acetabular loosening was the most frequent indication for the Revision THA cohort, while indications for tumour varied across primary presentations, metastases and failures of previous resection/reconstruction. Intraoperative complications were observed in 4.1% (95%CI 1.1-12.3) of Tumour Pelvis cases. Overall implant retention was 96% (90-99). No mortality events were observed in the Revision THA cohort, with 5-year patient survival 79% (70-90) in the Tumour Pelvis cohort. Procedure-survival free from periprosthetic infection was 86% (74-100) in the Revision THA cohort and 85% (76-95) in the Tumour Pelvis cohort. Modelling adverse events using multistate survival models in both cohorts revealed complex time-varying presentation of adverse events, with a significant burden of reoperations and local tumour recurrence in the Tumour Pelvis cohort.
3DPIs are a safe and viable option for complex reconstruction of the pelvis across a range of oncological and non-oncological indications. The initial results of the present study provide important information to aid in counselling patients about such procedures and allocating healthcare resources for ongoing care. Further work is required to document functional and biomechanical outcomes in these patient populations.
Australian New Zealand Clinical Trials Registry (ANZCTRN 12621001421820); Registration date 21-Oct-2021.
定制3D打印骨盆植入物（3DPI）在关节置换翻修术和肿瘤重建中的应用越来越广泛。关于此类植入物用于骨盆大骨缺损的安全性和效果的证据有限。本研究的目的是报告在骨盆肿瘤切除或全髋关节置换术（THA）失败后出现广泛骨盆骨缺损的情况下，使用定制3D打印假体进行骨盆重建后并发症的发生率、患者死亡率和植入物存活率。
从我们的临床结果登记处（复杂重建和肉瘤手术结果登记处；ANZCTRN 12621001421820）中识别出接受定制3D打印骨盆假体（3DPI）重建的患者。记录手术指征、不良事件、再次手术以及失败率和失败模式。根据指征生成Kaplan-Meier生存曲线和多状态生存曲线以计算累积生存率。
共完成了106例手术（翻修THA = 33例；肿瘤骨盆 = 73例），中位随访时间为4.1年，范围从0.6年至10年。髋臼松动是翻修THA队列中最常见的指征，而肿瘤患者的指征因原发表现、转移和既往切除/重建失败而有所不同。在4.1%（95%CI 1.1 - 12.3）的肿瘤骨盆病例中观察到术中并发症。总体植入物保留率为96%（90 - 99）。在翻修THA队列中未观察到死亡事件，肿瘤骨盆队列中5年患者生存率为79%（70 - 90）。翻修THA队列中无假体周围感染的手术生存率为86%（74 - 100），肿瘤骨盆队列中为85%（76 - 95）。在两个队列中使用多状态生存模型对不良事件进行建模，结果显示不良事件呈现复杂的随时间变化情况，肿瘤骨盆队列中再次手术和局部肿瘤复发的负担较重。
3DPI是一种安全可行的选择，可用于一系列肿瘤和非肿瘤指征的骨盆复杂重建。本研究的初步结果提供了重要信息，有助于为患者提供此类手术的咨询，并为持续护理分配医疗资源。需要进一步开展工作以记录这些患者群体的功能和生物力学结果。
澳大利亚新西兰临床试验注册中心（ANZCTRN 12621001421820）；注册日期2021年10月21日。
