Does the neutral zone quantification method matter? Efficacy of evaluating neutral zone during destabilization and restabilization in human spine implant testing.

Abstract Neutral zone (NZ) is an important biomechanical parameter when evaluating spinal instability following destabilizing and restabilizing events, with particular relevance for implant efficacy testing. It remains unclear what NZ calculation methods are most sensitive at capturing NZ changes across treatment conditions and a direct comparison is needed. The purpose of this study was to determine the most sensitive method at quantifying instability in human spines. Six cadaveric lumbar motion segments were subjected to a repeated measures implant testing schema of four sequential conditions: (1) Intact, (2) injury by herniation, (3) device implantation, (4) long-term cyclic fatigue loading. NZ was expected to increase after destabilization (steps 2 & 4) and decrease after restabilization (step 3). NZ methods compared in this study were: trilinear (TL), double sigmoid (DS), zero load (ZL), stiffness threshold (ST), and extrapolated elastic zone (EEZ). TL, ZL, and EEZ identified statistically significant NZ differences after each condition in flexion/extension and lateral bending. The ZL method also captured differences in axial rotation. All methods identified expected NZ trends after destabilization and restabilization, except DS in axial rotation. The TL, ZL, and EEZ methods were the most sensitive methods with this human cadaveric dataset. Future investigations comparing methods with additional datasets will clarify outcome generalizability and determine what curve profiles are most suitable for DS and ST methods. Understanding the applicability of NZ methods can enhance rigor and reliability of spinal instability measurements when quantifying the efficacy of novel implants and permits insight into clinically relevant biomechanical changes.