A prospective comparative study of outcomes between zero-profile 3D-printed interbody cages and plate-augmented cages in anterior cervical discectomy and fusion

To compare the clinical and radiographic outcomes between a zero-profile 3D-printed microporous titanium alloy (3D-ZP) cage and a traditional polyetheretherketone (PEEK) cage with an anterior plate in patients undergoing single-level anterior cervical discectomy and fusion (ACDF) for cervical spondylotic myelopathy (CSM). A prospective, open-label randomized controlled trial was conducted from January 2022 to January 2024. Patients diagnosed with single-level CSM were randomized to receive either a 3D-ZP cage or a PEEK cage with an anterior plate. The primary outcome was prosthesis subsidence rate. Secondary outcomes included operative time, incidence of dysphagia, visual analog scale (VAS) for neck pain, Japanese Orthopedic Association (JOA) score, Neck Disability Index (NDI), segmental Cobb angle, and fusion status. Follow-ups were conducted at 1 week, 3, 12, and 24 months postoperatively. A total of 113 patients completed the 24-month follow-up (3D-ZP group: n = 52, PEEK group: n = 61). The 3D-ZP group demonstrated a significantly lower prosthesis subsidence rate compared to the PEEK group (9.6% vs. 27.9%; RR = 0.35, 95% CI 0.14–0.87, P = 0.015). Operative time was shorter in the 3D-ZP group (65.63 ± 11.42 vs. 78.64 ± 14.81 min; MD=–13.00, 95% CI − 18.00 to − 8.01, P < 0.001). The incidence of dysphagia was also lower in the 3D-ZP group at both 1-week (13.5% vs. 45.9%, RR = 0.29, 95% CI 0.14–0.62, P < 0.001) and 24-month follow-ups (1.9% vs. 21.3%; RR = 0.09, 95% CI 0.01–0.67, P = 0.002). No significant differences were observed in JOA improvement rate or fusion rate between the two groups. Radiographically, the 3D-ZP group maintained significantly greater disc space height and segmental lordosis at 24 months. In single-level ACDF for CSM, the zero-profile 3D-printed titanium cage offers advantages over the traditional PEEK-and-plate construct, including shorter operative time, reduced incidence of dysphagia, and lower prosthesis subsidence rate, while achieving comparable neurological recovery and fusion outcomes.