Purpose: ALIF with cages is expected to restore disc height and stabilize the spine promoting fusion, while avoiding damage attributed to rod-pedicle screw fixation. However, it may be related to an increased risk of fusion failure and subsidence. A prospective study was conducted by five investigators across three centers to confirm performance of a PEEK cage for stand-alone ALIF in the treatment of lumbar degenerative disc disease (DDD).
Methods: Sixty-five patients, with back ± leg pain, requiring surgery for DDD, were included. Efficacy and safety were evaluated at 6 weeks, 3, 6, and 12 months post-operatively. Fusion and subsidence were assessed through CT-images at 12-month follow-up. Disc height was measured. Clinical outcomes included back and leg pain (VAS), disability (Oswestry Disability Index), Quality of Life (Short-Form 36), and adverse events.
Results: The fusion and the subsidence rates were 96.3 and 2.0 %, respectively. ALIF surgery restored anterior and posterior disc height compared to baseline. There were no device-related serious adverse events, and no revision surgeries. Clinical outcomes improved significantly through 12-month follow-up.
Conclusion: Safety and efficacy of this stand-alone cage with integrated intracorporeal plates was confirmed through 12 months for treatment of degenerative conditions. The design of the cage and plates may contribute to the decreased subsidence rate observed.