Soda Mosope, Moatz Bradley, Asdourian Paul, Brooks Daina, Cunningham Bryan, McAfee Paul C
From the Department of Orthopaedic Surgery, MedStar Union Memorial Medical Center, Baltimore, MD.
J Am Acad Orthop Surg Glob Res Rev. 2025 May 14;9(5). doi: 10.5435/JAAOSGlobal-D-24-00245. eCollection 2025 May 1.
The primary objective was to investigate the perioperative parameters and clinical outcomes of a novel three-dimensional (3D) printed titanium interbody spacer and integral screws. The secondary objective was to compare the survivorship rate of the 3D-printed titanium integrated spacer (3D-printed spacer group) with that of a polyether-ether-ketone (PEEK) integrated spacer (PEEK group) and traditional allograft spacer combined with an anterior cervical plate (control group).
This is a retrospective study comprising 157 consecutive patients (representing 300 surgical levels) investigating the perioperative and clinical outcomes of a novel 3D-printed titanium integrated spacer for anterior cervical diskectomy and fusion (ACDF).
A consecutive series of 157 patients (N = 300 surgical levels) presenting with cervical radiculopathy, myelopathy, or spondylosis underwent ACDF with the 3D-printed titanium spacer. Perioperative outcomes including surgical time, estimated blood loss, length of hospital stay, and number of surgical levels were collected. Clinical outcomes including the American Spinal Injury Association neurologic impairment score and Neck Disability Index (NDI) were measured preoperatively and postoperatively. Survivorship was defined as no failures, no anterior revision surgeries, no instrumentation removals, and no subsidence requiring surgery.
The mean surgical time for the 3D-printed spacer group was 126.3 ± 34.0 minutes, the estimated blood loss was 85.9 ± 30.5 cc, and the length of hospital stay was 1.5 ± 1.4 days. Surgical levels were distributed as follows: 33.8% single-level, 42.7% two-level, 21.6% three-level, and 1.9% four-level ACDF procedures. 98.7% of patients in the 3D-printed spacer group reported improved American Spinal Injury Association scores. The mean NDI preoperatively was 37.2 ± 18.7, and the mean NDI postoperatively was 21.2 ± 18.3, with 58.6% of patients reporting NDI improvement of 15% or greater. Survivorship was observed in 97.4% of patients in the 3D-printed spacer group, 98.0% in the PEEK group, and 93.3% in the control group (chi-square analysis: X2 [1, N = 1529] = 16.9, P = 0.0002).
A novel 3D-printed titanium spacer with integral screws for ACDF demonstrated improved survivorship rates compared with the traditional allograft spacer and anterior plate. Among 157 patients, only two required supplemental posterior fixation, one required removal for excessive kyphosis and were successfully revised with a 3D-printed corpectomy spacer, and one had notable subsidence at 6 weeks postoperatively (4 total failures based on the survivorship criteria; 97.4% survivorship success rate (153/157 patients)). Not a single case of neurologic progression was observed in the 3D-printed spacer group-no iatrogenic progressive radiculopathy nor myelopathy, unlike the control group.
主要目的是研究一种新型三维（3D）打印钛椎间融合器及一体式螺钉的围手术期参数和临床结果。次要目的是比较3D打印钛一体化融合器组（3D打印融合器组）与聚醚醚酮（PEEK）一体化融合器组（PEEK组）以及传统同种异体骨融合器联合前路颈椎钢板组（对照组）的生存率。
这是一项回顾性研究，纳入了157例连续患者（代表300个手术节段），旨在研究一种新型3D打印钛一体化融合器用于前路颈椎间盘切除融合术（ACDF）的围手术期和临床结果。
连续157例出现颈神经根病、脊髓病或颈椎病的患者（N = 300个手术节段）接受了使用3D打印钛融合器的ACDF手术。收集围手术期结果，包括手术时间、估计失血量、住院时间和手术节段数。测量临床结果，包括术前和术后的美国脊髓损伤协会神经损伤评分和颈部功能障碍指数（NDI）。生存率定义为无失败、无前路翻修手术、无器械取出以及无需要手术的下沉。
3D打印融合器组的平均手术时间为126.3±34.0分钟，估计失血量为85.9±30.5毫升，住院时间为1.5±1.4天。手术节段分布如下：单节段ACDF手术占33.8%，双节段占42.7%，三节段占21.6%，四节段占1.9%。3D打印融合器组98.7%的患者报告美国脊髓损伤协会评分有所改善。术前平均NDI为37.2±18.7，术后平均NDI为21.2±18.3，58.6%的患者报告NDI改善15%或更多。3D打印融合器组97.4%的患者观察到生存率，PEEK组为98.0%，对照组为93.3%（卡方分析：X2[1, N = 1529] = 16.9，P = 0.0002）。
一种新型带一体式螺钉的3D打印钛融合器用于ACDF，与传统同种异体骨融合器和前路钢板相比，生存率有所提高。在157例患者中，只有2例需要补充后路固定，1例因后凸畸形过大需要取出，并成功采用3D打印椎体切除融合器进行翻修，1例术后6周出现明显下沉（根据生存率标准共4例失败；97.4%的生存率成功率（153/157例患者））。3D打印融合器组未观察到一例神经功能进展病例——与对照组不同，没有医源性进行性神经根病或脊髓病。
