Object: The Graf pedicle screw and ligament device is designed to provide flexible stabilization to prevent abnormal spinal movement. The purpose of this study was to investigate radiographic and clinical outcomes during a minimal 5-year follow-up period.
Methods: Between 1991 and 1997, 43 consecutive patients (whose mean age was 61 years) with lumbar degenerative disease underwent decompression and stabilization in which the Graf system was placed. Data were available for 31 patients who attended follow up for the minimal 5-year period. In a retrospective review, the authors assessed measurements on radiographs, clinical results (using Japanese Orthopaedic Association [JOA] Scale scores), and low-back pain (using a visual analog scale [VAS] score), preoperatively and postoperatively at 1, 3, 5, and/or 10 years. Radiographic measurements included sagittal and frontal range of motion (ROM), regional lordosis, and posterior disc height as well as the extent of degenerative spondylolisthesis. Final follow-up JOA and VAS scores were significantly better than preoperative scores. Sagittal and frontal ROM was significantly reduced at 1 and 5 years, respectively, compared with preoperative values, and a gradual reduction persisted throughout the follow-up period. Compared with its preoperative status, the disc height ratio (adjacent segments to the operated level) was reduced 5 years after surgery. A significant inhibition of the vertebral slippage was detected only in the flexion position.
Conclusions: Analysis of these data indicated that the Graf system eventually leads to successful fusion, suggesting the presence of stability in all three dimensions. The use of the Graf system should continue to be evaluated as an alternative device in the treatment of lumbar degenerative disease.