Evaluation and analysis of patient outcomes with an intrasegmental fixation system in lumbar spinal fusion

A new spinal fixation system with polydirectional screws and modular links with interconnecting radial serrations has been developed. The system allows the linking of multiple points of fixation, two points at a time (intrasegmental fixation), thus eliminating the need for intraoperative contouring of rods or plates.

Evaluation of this new type of spine system was done through biomechanical studies, analysis of lumbar lordosis preservation postoperatively, and multicenter review of patient outcomes with a minimum of 1 year follow-up.

Biomechanical studies of the spine system were performed according to American Society for Testing and Materials (ASTM) standards. To evaluate the maintenance of lordosis, radiographs from the first 119 patients were reviewed by the authors. Analysis of patient outcomes consisted of a review of the first 259 patients who underwent spinal fusion surgery with the new spine system.

Evaluation of patient outcomes consisted of 122 men and 137 women with an average age of 50+/-13 years (range, 22-96 years) and a mean follow-up of 20+/-6 months (range, 12-54 months). The patient population was at high risk for fusion failure, with 127 smokers (49%), 141 who had previous spine surgery (54%), 22 with osteoporosis (8%), 63 were obese (24%), and 32 with diabetes (12%). One hundred two patients (39%) had a one-level fusion, 105 patients (41%) had two levels fused, and 52 patients (20%) had three or more levels fused. The majority of patients (66%) were covered under workers' compensation. OUTCOME MEASURES/METHODS: Radiographic fusion was deemed successful when the presence of trabecular bridging bone from transverse process to transverse process was observed, as well as no fixation failure nor radiographic evidence of screw loosening. Clinical success was rated excellent, good, fair, or poor depending on the patients pain level, function, and pain medication intake.

Biomechanical studies of this intrasegmental fixation system have shown it to be strong under both static and fatigue testing, with exceptional strength in compression bending. In evaluating preservation of lumbar lordosis, no statistically significant loss of lordosis was observed. Overall, radiographic fusion was noted in 229 of 259 patients (88%) and did not differ significantly (p>.10) by the number of levels fused. Clinically, 69 patients (27%) had an excellent result, 111 patients (43%) had a good result, 50 patients (19%) had a fair result, and 29 patients (11%) had a poor result. The high rate of successful patient outcomes did not differ significantly (p>.10) by the number of levels fused, or other patient or surgical variables, except for the satisfaction level of workers' compensation versus nonworkers' compensation. One hundred of 118 patients (85%) who were working before surgery returned to work at an average 9+/-4 months postoperatively (range, 2-20 months). The use of direct current (DC) stimulation in this population was reserved for patients with one or more risk factors for fusion failure and was noted to be of benefit. There were no recorded intraoperative complications, but postoperatively 5 device and 19 non-device-related complications (9%) were noted, which is comparable to other lumbar fusion series.

The results of these analyses show consistent patient outcomes regardless of the number of levels fused with an intrasegmental system. This may be attributable to the increased biomechanical strength of the system at each segment, coupled with the ability of intrasegmental fixation to maintain sagittal plane balance through preservation of the patient's lordotic curve.