Abstract
Purpose:
The purpose of the study was to evaluate the safety and efficacy of fixation of the lumbar spine, without fusion, using the Cosmic Pedicle Fixation System.
Method:
Prospective study of 107 patients selected to have either a completely non fused fixation (40 patients), and 67 who underwent a hybrid fusion. During the same period 299 standard fusions were performed at same institution.
Enrolment was from January 2006 to August 2008. Appropriate consent was obtained, but the choice of which levels to fuse and which levels to fix only was the surgeon's choice. Pre-operative ODI and VAS scores were obtained as well as parameters of sitting, standing and walking potential. Regular follow-up visits were done, and these parameters were controlled together with regular x-rays at each visit at 6 weeks, 6 months and 12 months and annually thereafter. Intra-operative blood loss, hospital stay and any adverse reaction or complications were documented.
Results:
The average follow up was more than 3 years. Average age at surgery was 62 years. Most were treated for spinal stenosis (79/107). Average VAS score improved from 8 to 2.2. ODI score improved from 50 to 14 (at 12 months), but there was a slight deterioration with time and aging. All improved dramatically on walking distances and sitting time.
Revision surgery was required in 10 patients, of which only 5 had fusions performed at the previously non fused segment. Screw breakage occurred in a number of patients but was not correlated to poor outcomes.
Average blood loss was 336 ml while hospital stay was only 3 days.
Conclusion:
Cosmic fixation without fusion is safe, giving comparable results to fusion with less complications, shorter hospital stay and very modest blood loss. Although not measured as such, pain control and use of opioids were deemed much less than conventional fusion surgery.
