Background: Several clinical studies have documented long-term adjacent-level effects of spinal fusion, due to stress concentration and motion loss at the fused segment. Non-fusion motion preservation devices are designed to eliminate or slow down such adverse effects. Therefore, appropriate biomechanical evaluation of the adjacent-level effects in spine is important and timely. Although many biomechanical studies are available and have provided some understanding of the adjacent-level effects, results have large variation and are conflicting, mostly due to the use of inappropriate and ill-defined methods. A new test method especially designed to study spinal adjacent-level effects is needed.
Methods: The proposed Hybrid method uses unconstrained pure moment to provide rotation-input for multi-directional testing. The new method has four steps: (1) Intact spine specimen with entire mobile region is used. The specimen is prepared to measure various biomechanical parameters, e.g., disc pressures, ligament strains, and facet loads. (2) Appropriate unconstrained pure moment is applied to the intact specimen and total range of motion is determined. (3) Unconstrained pure moment is applied to the spinal construct (specimen with an implant) until the total range of motion of the construct equals that of the intact. (4) Statistical comparison of the biomechanical parameters between the construct and intact quantifies the adjacent-level effects.
Findings: The uniqueness of the proposed method, to study the adjacent level effects due to fusion and non-fusion devices, is that it applies the needed rotation-input to the spine specimen, using available methodology with minimal modification.
Interpretation: Previous studies have lacked appropriate and well-defined methodologies to evaluate spinal adjacent-level effects. The proposed method uses well-known methodology and yields high quality, and laboratory-independent results for the fusion and non-fusion devices.