[Comparation on clinical outcomes of 3D-printed intelligent manufacturing bionic artificial cervical disc versus...

Objective: To compare the clinical efficacy of a 3D-printed intelligently manufactured biomimetic artificial cervical disc (with independent intellectual property rights) versus the Prestige LP artificial cervical disc in the treatment of degenerative cervical spondylosis. Methods: A retrospective analysis was conducted on clinical data from patients who underwent cervical disc replacement with either the Prestige LP or a domestically produced 3D-printed artificial cervical disc at Xi'an Honghui Hospital, Xi'an Jiaotong University, between May 2019 and December 2022, and all completed the follow-up. The two groups of patients were compared in terms of clinical efficacy [including Visual Analogue Scale (VAS) of pain, Japanese Orthopaedic Association (JOA) score, Neck Disability Index (NDI), and Odom's criteria], operative time, intraoperative blood loss, early complications (intraoperative adjacent organ injury, hematoma formation), postoperative cervical range of motion (ROM), incidence of heterotopic ossification (HO), and adjacent segment degeneration (ASD). Results: A total of 68 patients were enrolled, including 36 males and 32 females, with a mean age of (48.2±2.8) years. Among them, 33 patients received the Prestige LP disc, and 35 received the 3D-printed disc. The mean follow-up duration was (34.6±2.0) months in the Prestige LP group and (32.8±3.0) months in the 3D-printed group. There were no significant differences in baseline data, blood loss, drainage, or total hospitalization costs between groups (all P>0.05). The 3D-printed group had significantly shorter operative time (P=0.020) but significantly longer hospital stay (P=0.001) than the Prestige LP group. At the final follow-up, the VAS score in the Prestige LP group decreased from (7.0±1.6) to (1.7±0.1), and the Neck Disability Index (NDI) score decreased from (26.0±4.1) to (9.6±1.2); in the 3D-printed group, the VAS score decreased from (6.3±1.6) to (1.6±0.2), and the NDI score decreased from (29.0±3.7) to (10.1±1.7) (all P<0.05), of which intergroup differences were not statistically significant (all P>0.05). The JOA recovery rate was 78.9%±13.6% in the Prestige LP group and 82.2%±12.4% in the 3D-printed group, with no significant difference (P=0.845). The excellent-to-good rate was 90.9% (30/33) in the Prestige LP group and 88.6% (31/35) in the 3D-printed group, also without significant difference (P=0.800). Radiographically, no significant loss of segmental ROM was observed in either group at the final follow-up (both P>0.05). The incidences of HO and ASD at the final follow-up were significantly lower in the 3D-printed group [8.6% (3/35) and 5.7% (2/35), respectively] compared with the Prestige LP group [15.2% (5/33) and 12.1% (4/33), respectively] (both P<0.05). No severe perioperative complications occurred in either group, and no reoperations related to the index surgery were reported during the follow-up period. Conclusions: The 3D-printed artificial cervical disc achieves comparable clinical efficacy to the Prestige LP artificial cervical disc. Moreover, during early follow-up, it demonstrates advantages over the Prestige LP disc in terms of lower rates of subsidence, loosening, heterotopic ossification, and adjacent segment degeneration.