Evaluation of Healthcare Outcomes of Patients Treated with 3D-Printed-Titanium and PEEK Cages During Fusion Procedures in the Lumbar Spine.

IF 1.3 Q4 ENGINEERING, BIOMEDICAL Medical Devices-Evidence and Research Pub Date : 2025-01-16 eCollection Date: 2025-01-01 DOI:10.2147/MDER.S493988
Katherine A Corso, Andreas A Teferra, Annalisa Michielli, Kristin Corrado, Amy Marcini, Mark Lotito, Caroline Smith, Michelle Costa, Jill Ruppenkamp, Anna Wallace
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Abstract

Purpose: The objective of this observational, real-world study was to describe reoperation, revision, index healthcare utilization and hospital costs among patients treated with PEEK (polyetheretherketone) or 3D-printed-titanium cages during lumbar/lumbosacral posterior fusion procedures, either TLIF (transforaminal lumbar interbody fusion) or PLIF (posterior lumbar interbody fusion). Statistical comparisons were not conducted.

Methods: This was a descriptive, retrospective, observational study. Patients with PEEK (OPAL™, DePuy Synthes, Raynham, MA) or 3D-printed-titanium (CONDUIT™ TLIF (transforaminal lumbar interbody fusion)/PLIF (posterior lumbar interbody fusion) Cage/EIT™ Cellular Titanium TLIF/PLIF Cage (DePuy Synthes, Raynham, MA)) spinal cages were identified in the Premier Healthcare Database between 1/1/2007 and 9/30/2022. Patients were required to have posterior approaches of the lumbar/lumbosacral spine and DDD, stenosis, back pain, instability, spondylolisthesis, or pseudarthrosis/failed prior surgery. Patient and procedure, healthcare utilization and hospital cost data were collected at the index surgery, and patients were followed up to 3 months for reoperation and 12 months for revision. All data were summarized descriptively, and no statistical comparisons were made between cage groups.

Results: A total of 5118 PEEK and 1189 3D-printed-titanium cage patients were included in this study. Among 3D-printed-titanium cages, 804 had PLIF and 345 had Curved TLIF cage types. Most PEEK cage patients were 18-64 years (61.9%), and 3D-printed-titanium was evenly distributed across age categories. The mean index hospital cost was ~$40,000, LOS was ~3 days, and discharge status to home/home health was ~85% for both; surgery time was 267 minutes for PEEK and 280 minutes for 3D-printed-titanium. The 0-3 month reoperation cumulative incidence was 1.0% for PEEK and 1.3% for 3D-printed-titanium. For revision, incidence within 0-3, 4-6, and 7-12 months was 1.2%, 0.6%, and 1.7% for PEEK and 1.6%, 0.5%, and 1.2% for 3D-printed-titanium. The mean costs per patient associated with reoperation and revision for the entire cohort were $220 and $1228 for PEEK and $290 and $1754 for 3D-printed-titanium.

Conclusion: This study provides real-world economic insights into an area where practice data are sparse, within hospital settings for PEEK and 3D-printed-titanium spinal cages. A key study limitation is the descriptive design in which potential confounding factors that may affect the outcome estimates are not addressed.

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在腰椎融合术中使用3d打印钛和PEEK笼治疗患者的医疗保健结果评估
目的:这项观察性的真实世界研究的目的是描述在腰椎/腰骶后路融合术中使用PEEK(聚醚醚酮)或3d打印钛笼治疗的患者的再手术、翻修、指数保健利用和住院费用,无论是TLIF(经椎间孔腰椎体间融合术)还是PLIF(后路腰椎体间融合术)。未进行统计学比较。方法:这是一项描述性、回顾性、观察性研究。2007年1月1日至2022年9月30日期间,在Premier Healthcare数据库中确定了PEEK (OPAL™,DePuy Synthes, Raynham, MA)或3d打印钛(CONDUIT™TLIF(经椎间孔腰椎体间融合术)/PLIF(后路腰椎体间融合术)Cage/EIT™Cellular Titanium TLIF/PLIF Cage (DePuy Synthes, Raynham, MA))脊柱笼患者。患者需要有腰椎/腰骶椎后路入路和DDD、狭窄、背痛、不稳定、腰椎滑脱或假关节/先前手术失败。在首次手术时收集患者和手术、医疗保健利用和医院费用数据,随访患者3个月进行再次手术,12个月进行翻修。所有数据进行描述性汇总,各组间无统计学比较。结果:共纳入5118例PEEK患者和1189例3d打印钛笼患者。3d打印钛笼中,PLIF型804个,Curved TLIF型345个。大多数PEEK笼患者年龄为18-64岁(61.9%),3d打印钛均匀分布在各个年龄段。平均指数住院费用为~ 40000美元,LOS为~3天,出院状态为~85%;PEEK手术时间为267分钟,3d打印钛手术时间为280分钟。0-3个月的再手术累计发生率PEEK为1.0%,3d打印钛为1.3%。修正后,0-3、4-6和7-12个月内PEEK的发病率分别为1.2%、0.6%和1.7%,3d打印钛的发病率分别为1.6%、0.5%和1.2%。在整个队列中,每位患者与再手术和翻修相关的平均费用为PEEK为220美元和1228美元,3d打印钛为290美元和1754美元。结论:本研究为医院设置PEEK和3d打印钛脊柱笼的实践数据稀少的领域提供了现实世界的经济见解。研究的一个关键限制是描述性设计,其中可能影响结果估计的潜在混杂因素没有得到解决。
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来源期刊
Medical Devices-Evidence and Research
Medical Devices-Evidence and Research ENGINEERING, BIOMEDICAL-
CiteScore
2.80
自引率
0.00%
发文量
41
审稿时长
16 weeks
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