Prospective clinical and radiographic evaluation of an allogeneic bone matrix containing stem cells (Trinity Evolution® Viable Cellular Bone Matrix) in patients undergoing two-level anterior cervical discectomy and fusion

Abstract Background Trinity Evolution® (TE), a viable cellular bone allograft, previously demonstrated high fusion rates and no safety-related concerns after single-level anterior cervical discectomy and fusion (ACDF) procedures. This prospective multicenter clinical study was performed to assess the radiographic and clinical outcomes of TE in subjects undergoing two-level ACDF procedures. Methods In a prospective, multicenter study, 40 subjects that presented with symptomatic cervical degeneration at two adjacent vertebral levels underwent instrumented ACDF using TE autograft substitute in a polyetherethereketone (PEEK) cage. At 12 months, radiographic fusion status was evaluated by dynamic motion plain radiographs and thin cut CT with multiplanar reconstruction by a panel that was blinded to clinical outcome. Fusion success was defined by angular motion (≤4°) and the presence of bridging bone across the adjacent vertebral endplates. Clinical pain and function assessments included the Neck Disability Index (NDI), neck and arm pain as evaluated by visual analog scales (VAS), and SF-36 at both 6 and 12 months. Results At both 6 and 12 months, all clinical outcome scores (SF-36, NDI, and VAS pain) improved significantly (p < 0.05) compared to baseline values. There were no adverse events or infections that were attributed to the graft material, no subjects that required revisions, and no significant decreases to mean neurological evaluations at any time as compared to baseline. At 12 months, the per subject and per level fusion rate was 89.4 and 93.4%, respectively. Subgroup analysis of subjects with risk factors for pseudoarthrosis (current or former smokers, diabetic, or obese/extremely obese) compared to those without risk factors demonstrated no significant differences in fusion rates. Conclusions Patients undergoing two-level ACDF with TE in combination with a PEEK interbody spacer and supplemental anterior fixation had a high rate of fusion success without any serious adverse events related to the graft material. Trial registration Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF) NCT0095193

A biomechanical analysis of the self-retaining pedicle hook device in posterior spinal fixation

Regular hooks lack initial fixation to the spine during spinal deformity surgery. This runs the risk of posterior hook dislodgement during manipulation and correction of the spinal deformity, that may lead to loss of correction, hook migration, and post-operative junctional kyphosis. To prevent hook dislodgement during surgery, a self-retaining pedicle hook device (SPHD) is available that is made up of two counter-positioned hooks forming a monoblock posterior claw device. The initial segmental posterior fixation strength of a SPHD, however, is unknown. A biomechanical pull-out study of posterior segmental spinal fixation in a cadaver vertebral model was designed to investigate the axial pull-out strength for a SPHD, and compared to the pull-out strength of a pedicle screw. Ten porcine lumbar vertebral bodies were instrumented in pairs with two different instrumentation constructs after measuring the bone mineral density of each individual vertebra. The instrumentation constructs were extracted employing a material testing system using axial forces. The maximum pull-out forces were recorded at the time of the construct failure. Failure of the SPHD appeared in rotation and lateral displacement, without fracturing of the posterior structures. The average pull-out strength of the SPHD was 236 N versus 1,047 N in the pedicle screws (P < 0.001). The pull-out strength of the pedicle screws showed greater correlation with the BMC compared to the SPHD (P < 0.005). The SPHD showed to provide a significant inferior segmental fixation to the posterior spine in comparison to pedicle screw fixation. Despite the beneficial characteristics of the monoblock claw construct in a SPHD, that decreases the risk of posterior hook dislodgement during surgery compared to regular hooks, the SPHD does not improve the pull-out strength in such a way that it may provide a biomechanically solid alternative to pedicle screw fixation in the posterior spine