Biomechanical Stability of a Stand-Alone Interbody Spacer in Two-Level and Hybrid Cervical Fusion Constructs

STUDY DESIGN In vitro human cadaveric biomechanical analysis. OBJECTIVE To evaluate the segmental stability of a stand-alone spacer (SAS) device compared with the traditional anterior cervical plate (ACP) construct in the setting of a 2-level cervical fusion construct or as a hybrid construct adjacent to a previous 1-level ACP construct. METHODS Twelve human cadaveric cervical spines (C2-T1) were nondestructively tested with a custom 6-degree-of-freedom spine simulator under axial rotation (AR), flexion-extension (FE), and lateral bending (LB) at 1.5 N m loads. After intact analysis, each specimen underwent instrumentation and testing in the following 3 configurations, with each specimen randomized to the order of construct: (A) C5-7 SAS; (B) C5-6 ACP, and C6-7 SAS (hybrid); (C) C5-7 ACP. Full range of motion (ROM) data at C5-C7 was obtained and analyzed by each loading modality utilizing mean comparisons with repeated measures analysis of variance with Sidak correction for multiple comparisons. RESULTS Compared with the intact specimen, all tested constructs had significantly increased segmental stability at C5-C7 in AR and FE ROM, with no difference in LB ROM. At C5-C6, all test constructs again had increased segmental stability in FE ROM compared with intact (10.9° ± 4.4° Intact vs SAS 6.6° ± 3.2°, P < .001; vs.Hybrid 2.9° ± 2.0°, P = .005; vs ACP 2.1° ± 1.4°, P < .001), but had no difference in AR and LB ROM. Analysis of C6-C7 ROM demonstrated all test groups had significantly greater segmental stability in FE ROM compared with intact (9.6° ± 2.7° Intact vs SAS 5.0° ± 3.0°, P = .018; vs Hybrid 5.0° ± 2.7°, P = .018; vs ACP 4.4° ± 5.2°, P = .005). Only the hybrid and 2-level ACP constructs had increased stability at C6-C7 in AR ROM compared with intact, with no difference for all test groups in LB ROM. Comparison between test constructs demonstrated no difference in C5-C7 and C6-C7 segmental stability in all planes of motion. However, at C5-C6 comparison between test constructs found the 2-level SAS had significantly less segmental stability compared to the hybrid (6.6° ± 3.2° vs 2.9° ± 2.0°, P = .025) and ACP (6.6° ± 3.2° vs 2.1° ± 1.4°, P = .004). CONCLUSIONS Our study found the currently tested SAS device may be a reasonable option as part of a 2-level hybrid construct, when used below an adjacent 1-level ACP, but should be used with careful consideration as a 2-level SAS construct. Consequences of decreased segmental stability in FE are unknown; however, optimal immediate fixation stability is an important surgical principle to avoid loss of fixation, segmental kyphosis, interbody graft subsidence, and pseudarthrosis.