Feasibility of the Non-Window-Type 3D-Printed Porous Titanium Cage in Posterior Lumbar Interbody Fusion: A Randomized Controlled Multicenter Trial.

Abstract

BACKGROUND Three-dimensionally printed titanium (3D-Ti) cages can be divided into 2 types: window-type cages, which have a void for bone graft, and non-window-type cages without a void. Few studies have investigated the necessity of a void for bone graft in fusion surgery. Therefore, the present study assessed the clinical and radiographic outcomes of window and non-window-type 3D-Ti cages in single-level posterior lumbar interbody fusion. METHODS A total of 70 patients were randomly assigned to receive either a window or non-window cage; 61 patients (87%) completed final follow-up (32 from the window cage group, 29 from the non-window cage group). Radiographic outcomes, including fusion rates, subsidence, and intra-cage osseointegration patterns, were assessed. Intra-cage osseointegration was measured using the intra-cage bridging bone score for the window cage group and the surface osseointegration ratio score for the non-window cage group. Additionally, we looked for the presence of the trabecular bone remodeling (TBR) sign on computed tomography (CT) images. RESULTS Of the 61 patients, 58 achieved interbody fusion, resulting in a 95.1% fusion rate. The fusion rate in the non-window cage group was comparable to, and not significantly different from, that in the window cage group (96.6% and 93.8%, p > 0.99). The subsidence rate showed no significant difference between the window and non-window cage groups (15.6% and 3.4%, respectively; p = 0.262). The intra-cage osseointegration scores showed a significant difference between the groups (p = 0.007), with the non-window cage group having a higher proportion of cases with a score of 4 compared with the window cage group. The TBR sign was observed in 87.9% of patients who achieved interbody fusion, with a higher rate in the non-window cage group across the entire cohort although the difference was not significant (89.7% versus 78.1%, p = 0.385). CONCLUSIONS Non-window-type 3D-Ti cages showed equivalent clinical outcomes compared with window-type cages and comparable interbody fusion rates. These results suggest that the potential advantages of 3D-Ti cages could be optimized in the absence of a void for bone graft by providing a larger contact surface for osseointegration. LEVEL OF EVIDENCE Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.