Comparative Analysis of Biomechanical Stability and Pain Reduction in Novel TLIF Devices.

Objective: This study aims to evaluate the biomechanical and clinical performance of a new anti-backout TLIF device compared to a traditional device.

Methods: This study involved a rat model, with biomechanical tests including static axial compression, static and dynamic settlement, and blade-cutting torque tests. Pain behavior in rats (n = 6) and material compatibility through cell toxicity and hemolysis tests were also assessed.

Results: The modified anti-backout interbody fusion cage demonstrated a yield load of 7747.36 ± 274.96 N in static axial compression testing, significantly higher than the traditional TLIF cage's 6933.36 ± 65.00 N (p < 0.05), indicating superior load resistance. In static settlement testing, the modified cage's yield load was 1020.87 ± 13.22 N, also notably higher than the traditional cage's 939.06 ± 8.03 N (p < 0.05). In static pullout testing, the maximum pullout force of the modified cage with the blade extended reached 534.02 ± 21.24 N, exceeding the 476.97 ± 24.45 N without the blade (p < 0.05), showing advantages in maximum pullout force and stiffness. Biocompatibility tests revealed lower cytotoxicity and a hemolysis rate of less than 5% for the modified cage material, significantly better than the traditional material's 8% (p < 0.05).

Conclusion: The new anti-backout TLIF device provides enhanced stability, reduced pain, and improved material compatibility, supporting its potential for clinical application.