Lumbar facet arthroplasty with total spine system yielded low complication rates at 1 year
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CHICAGO — Results showed patients who underwent lumbar facet arthroplasty with a total spine system had low complication rates and significant improvements in patient-reported outcome measures at 1-year follow-up.
“Comparison of the [total posterior spine system] TOPS cohort to the control arm in the ongoing FDA clinical trial will be necessary to draw final conclusions regarding the noninferiority of the TOPS device,” Zachariah Pinter, MD, said in his presentation at the North American Spine Society Annual Meeting.
Pinter and colleagues assessed the development of device-related complications among 153 patients with grade 1 degenerative spondylolisthesis with symptomatic spinal stenosis who underwent lumbar facet arthroplasty with implantation of the TOPS system (Premia Spine) with at least 1-year follow-up. Researchers also assessed surgical variables, patient-reported outcome measures and preservation of radiographic motion at the index level at 12 months postoperatively.
“Complications occurred in 11 patients, and 13 reoperations were performed in nine patients,” Pinter said. “The vast majority of the complications and reoperations that occurred were not directly attributable to the TOPS device, but were inherent risks associated with performance of a wide decompression and placement of pedicle screws.”
Mean estimated blood loss was 205 ccs, mean surgical time was 188 minutes and mean length of stay was 3 days, Pinter said.
Beginning at 6 weeks postoperatively, patients had a significant improvement in all patient-reported outcome measures, which persisted through the 1-year postoperative follow-up, Pinter said. More than 80% of patients achieved the minimally clinical important difference in all patient-reported outcome measures at 1 year postoperatively.
“Lumbar facet arthroplasty with implantation of the TOPS device led to a significant reduction in mean spondylolisthesis from preoperative to postoperative,” Pinter said. “Furthermore, all bending motion parameters were maintained, and all operative segments remained mobile at 12 months postoperatively.”
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Pinter Z, et al. Paper 128. Presented at: North American Spine Society Annual Meeting; Oct. 12-15, 2022; Chicago.
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