Failure analysis of C-5 after total disc replacement with ProDisc-C at 1 and 2 levels and in combination with a fusion cage: finite-element and biomechanical models.

OBJECT The purpose of this study was to evaluate the failure risk of cervical vertebrae after total disc replacement with a keel-design prosthesis (ProDisc-C), taking into consideration the effects of vertebral body height, multilevel replacement, and the association with an adjacent fusion cage. Although promising clinical results have been reported for the ProDisc-C, some clinical studies have reported vertebral body-splitting fractures at single- and multilevel arthroplasty sites. This implant has central keels to provide solid initial stability, and some authors associate the potential risk of vertebral body failure with the keel design, especially in patients with small vertebral body height or when the implant is used at multiple levels. METHODS The study was performed using a specimen-specific C4-6 cervical-segment finite-element model to assess the compressive strains on the C-5 vertebral body for each cervical segment configuration, and synthetic polyurethane models to experimentally predict the compressive load at failure for 3 vertebral body heights. RESULTS The use of a keeled ProDisc-C prosthesis at multiple levels or in combination with a fusion cage increases by a factor of 2-3 the compressive strains at the C-5 vertebral body relative to single-level arthroplasty. All implanted segment configurations tested demonstrated a continuum of the load at failure and the vertebral body height, but no significant differences were found between the 3 vertebral body heights in each segment configuration. CONCLUSIONS The use of a keeled ProDisc-C prosthesis at 2 adjacent levels or combined with a fusion cage presented the lowest load-at-failure values, 2 times higher on average than the ones occurring during physiological tasks. This fact indicates an identical and limited risk of vertebral body failure for these 2 segment configurations, whereas vertebral body height appears to slightly affect this risk. However, for some tasks that place higher physical demands on the neck, beyond what was represented by our models, there may also be risk of microdamage initiation, which is not present in the single-level arthroplasty.