A prospective randomized cohort study on 3D-printed artificial vertebral body in single-level anterior cervical corpectomy for cervical spondylotic myelopathy

Background: This was a prospective randomized cohort study aiming at examining the safety and efficacy of artificial vertebral body (AVB) fabricated by electron beam melting (EBM) in comparison to conventional titanium mesh cage (TMC) used in single-level anterior cervical corpectomy and fusion (SL-ACCF).

Methods: Forty patients with cervical spondylotic myelopathy (CSM) underwent SL-ACCF using either the EBM-AVB or the TMC. Patients were evaluated for their demographics, radiological characteristics, neurologic function [using the Japanese Orthopaedic Association (JOA) scale], and health-related quality-of-life (HRQoL) aspects [using the Short Form 36 (SF-36)] before and after the surgery and comparison was made between the two groups both at baseline and the last follow-up. The Student t-text, paired-sample t-text, and Fisher's exact test were used when appropriate to detect any statistical significance at the level of α=0.05.

Results: Post-operative recovery was uneventful for all patients and no revision surgery was required. There were no significant differences between the EBM-AVB group and the TMC group at baseline. Patients in both groups demonstrated significant improvement in cervical alignment, JOA score, and SF-36 score after the surgery. Six months post-operatively, patients in the EBM-AVB group were found to have significantly less loss of fusion height and lower incidence for severe implant subsidence compared with the TMC group. Patients in the two groups were comparable at the last follow-up regarding their rate of fusion, cervical alignment, JOA recovery rate, SF-36 score, and by Odom's criteria.

Conclusions: For CSM patients undergoing SL-ACCF, the EBM-AVB group demonstrated comparable outcomes regarding patient cervical alignment, neurologic function, and HRQoL in comparison with the TMC group. Furthermore, the use of EBM-AVB was associated with decreased loss of the height of the fusion mass and a lower rate for severe implant subsidence.