Corso Katherine A, Kothari Prerna, Corrado Kristin, Michielli Annalisa, Ruppenkamp Jill, Bowden Dawn
Johnson & Johnson, Medical Devices, Medical Device Epidemiology and Real World Data Sciences, New Brunswick, NJ, USA.
Mu Sigma, Decision Sciences, Bangalore, India.
Expert Rev Med Devices. 2022 Feb;19(2):195-201. doi: 10.1080/17434440.2022.2020637. Epub 2021 Dec 22.
Three-dimensional (3D) printed spinal cages are a new design of intervertebral body fusion devices. Clinical data on these devices are limited. The objective of this study was to describe six-month events for a new and older cage design.
A retrospective, descriptive cohort study of patients that received a 3D-printed-titanium or PEEK (polyetheretherketone) cage with single-level lumbar fusion was performed using a United States hospital-based database. Outcomes evaluated were device-related revision and non-device related reoperation events 6 months after lumbar fusion. The 3D-printed-titanium and PEEK groups were propensity-score matched. Both unmatched and matched groups were descriptively analyzed. There were 93 and 2,082 patients with a 3D-printed-titanium and PEEK cage that met study criteria. The sample size was 93 patients per group after matching.
There were no occurrences of revisions in the 3D-printed-titanium and eleven occurrences in the PEEK group before matching; PEEK had no occurrences of revision after matching. Ten total reoperation events were identified.
Our findings suggest occurrence of 6-month revision or reoperation is similar or lower for both cages than reported in published literature. The low occurrence of early events for 3D-printed-titianium cages is promising. Further, real-world studies on 3D-printed cages are warranted.
三维(3D)打印脊柱融合器是椎间融合装置的一种新设计。关于这些装置的临床数据有限。本研究的目的是描述一种新型和旧型融合器设计在六个月时的情况。
使用美国一家医院的数据库,对接受3D打印钛合金或聚醚醚酮(PEEK)融合器进行单节段腰椎融合的患者进行一项回顾性描述性队列研究。评估的结果是腰椎融合术后6个月与装置相关的翻修和与装置无关的再次手术事件。对3D打印钛合金组和PEEK组进行倾向评分匹配。对未匹配组和匹配组均进行描述性分析。有93例接受3D打印钛合金融合器和2082例接受PEEK融合器的患者符合研究标准。匹配后每组样本量为93例患者。
匹配前,3D打印钛合金组未发生翻修,PEEK组发生11次翻修;匹配后PEEK组未发生翻修。共确定了十次再次手术事件。
我们的研究结果表明,两种融合器在6个月时的翻修或再次手术发生率与已发表文献报道的相似或更低。3D打印钛合金融合器早期事件发生率低,前景乐观。此外,有必要对3D打印融合器进行真实世界研究。