Meta-analysis of the efficacy and safety of 3D printed artificial vertebral body in spinal reconstruction after total en bloc spondylectomy for spinal tumors

English Keywords:Spinal tumor  3D printed  Artificial vertebral body  Total en bloc spondylectomy  Meta-analysis

English Abstract:

  【Abstract】 Objectives: To systematically analyze the clinical efficacy and safety of 3D printed artificial vertebral body in spinal reconstruction after total en bloc spondylectomy(TES) for spinal neoplasms. Methods: Databases such as PubMed, Embase, Cochrane Library, Web of Science, China Biology Medicine(CBM), CNKI, Wanfang, and VIP were searched to collect the clinical literature on the implantation of 3D-printed artificial vertebral body in spinal reconstruction after TES of spinal tumors from the establishment of each database to August 2022. The study type was non-randomized controlled trial, including double-arm trial(divided into 3D group and titanium mesh group according to different implants) and single-arm trial. The methodological index for non-randomized studies(MINORS) was used to assess the quality of the included studies. The data of outcome indicators of the included studies were extracted, including operative time, intraoperative blood loss, early complication rate, fusion rate of adjacent vertebral body, subsidence rate of implants, Frankel classification of spinal cord injury(A-E grade scored 1-5 points). Stata 14.0 software was used for meta-analysis. Results: A total of 13 relavant literature were included, 8 of which were single-arm clinical trials with a total sample size of 140 cases, and they were of moderate-quality with a literature score of 12-13 points each; and 5 of which were double-arm clinical trials with a total sample size of 115 cases in the 3D group and 126 cases in the titanium mesh group, and they were of high-quality with a literature score of 19-20 points each. The results of meta-analysis: double-arm trial showed lower operative time(MD=-287.14, 95%CI -391.30 to -182.99, P=0.00) and intraoperative blood loss(MD=-2.87, 95%CI -5.11 to -0.63, P=0.01) in the 3D group than in the titanium mesh group; single-arm trial showed the early complication rate was 23%(95％CI 0.16 to 0.31), and double-arm trial showed no significant difference in the early complication rate between the two groups(RR=0.56，95%CI 0.32 to 1.00, P=0.05); single-arm trial showed the Frankel classification of postoperative spinal cord injury was improved by about 1 grade than preoperation(MD=1.04, 95%CI 0.32 to 1.76, P=0.03), and double-arm trial showed no significant difference in the Frankel grade of postoperative spinal cord injury between the two groups(MD=-0.13, 95%CI -0.45 to 0.19, P=0.42); single-arm trial showed that the fusion rate with adjacent vertebral bodies was 93%(95%CI 0.79 to 1.00), while only 1 literature in double-arm trial reported fusion rate, so meta-analysis was not performed; single-arm trial showed that the subsidence rate of implants was 4%(95％CI 0.01 to 0.07), and double-arm trial showed the subsidence rate of implants in the 3D group was lower than that in the titanium mesh group(RR=0.15, 95%CI 0.05 to 0.45, P=0.001). Conclusions: The 3D-printed artificial vertebrae prosthesis in spinal reconstruction after TES of spinal tumors has the advantages of a short operative time, little intraoperative blood loss, high fusion rate of adjacent vertebrae, low subsidence rate of implants, good neurological function recovery of spinal cord injury after surgery, and significant curative effect.