Autograft versus interbody fusion cage without plate fixation in the cervical spine: a randomized clinical study using radiostereometry.

A primary object with a fusion cage is avoidance of graft collapse with subsequent subsidence and malalignment of the cervical spine that is observed after bone grafting alone. No randomized studies exist that demonstrate the difference between these two methods in terms of graft subsidence and angulation of the fused segment. The size of the study population was calculated to be 24 patients to reach a significant difference at the 95% CI level. Patients with one-level cervical radiculopathy scheduled for surgery were randomized to anterior discectomy and fusion (ACDF) with autograft or to fusion cage, both without plate fixation. Tantalum markers were inserted in the two adjacent vertebrae at the end of surgery. Radiostereometry was performed immediately postoperatively and at regular intervals for 2 years. Questionnaires were used to evaluate the clinical outcome and an unbiased observer graded the outcome after 2 years. No significant differences were found between the two methods after 2 years in regard of narrowing of the disc space (mean 1.7 and 1.4 mm, respectively) or deformation of the fused segment into flexion (mean 7.7 degrees and 4.6 degrees , respectively). Patients in the cage group had a significantly better clinical outcome. The findings of subsidence and flexion deformation of the fused segment after 2 years seem to be of no clinical importance after one-level cervical disc surgery. However, in multi-level surgery using the same methods, an additive effect of the deformations of the fused segments may affect the clinical outcome.

RCT Entities:   Population Interventions Outcomes