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.