Clinical and radiological evaluation of the Codman semiconstrained load-sharing anterior cervical plate: prospective multicenter trial and independent blinded evaluation of outcome.

OBJECT Semiconstrained load-sharing implants for spinal fixation accommodate change in the screw-plate interface as bone grafts shrink. The authors evaluated the clinical and radiological outcome in patients after placement of the Codman anterior cervical plate (ACP) system, which allows change in the screw-plate angle. METHODS The authors undertook a 10-center prospective study with independent blinded evaluation. All patients underwent cervical fusion and placement of ACPs. Clinical and radiological evaluations were performed at 1, 3, 6, 12, and 24 months. Radiographs were examined for screw angles, construct height, fusion, and screw fracture or displacement. One hundred ninety-five patients were enrolled. The mean follow-up period was 17 months. At 24 months neurological improvement was demonstrated in 68.7% and pain improvement in 76.6% of the patients. Fusion was successful in 93.8%. Varying degrees (most minor) of hardware-related failure occurred in 10.4% of cases; however, reoperation was required in only four (2.1%). A significant change in screw angles occurred over time (mean 6.4 degrees in caudal screw angle [p < 0.001] and 2.4 degrees in the rostral screw angle [p = 0.003]). These changes plateaued by 6 months. A change in construct height (mean 3.48 mm) occurred by 6 months (p < 0.05). CONCLUSIONS Based on an independent blinded evaluation, the Codman ACP provides effective fixation with load sharing and is effective in achieving fusion with a 94% success rate. Direct comparison with rigidly locked devices is required to establish definitively the optimal method for anterior cervical fixation.