Abstract
<h3>PURPOSE</h3> The purpose of the present study is to report the 1-year clinical and radiographic outcomes as well as safety profiles of patients who underwent lumbar facet arthroplasty via implantation of the TOPS device as part of a prospective Investigational Device Exemption (IDE) trial. <h3>STUDY DESIGN/SETTING</h3> Prospective FDA IDE trial. <h3>METHODS</h3> We reviewed the prospectively collected clinical and radiographic outcomes of patients who underwent facet arthroplasty via implantation of the TOPS device in the investigational arm of a multicenter, prospective, randomized, controlled FDA IDE trial. Standard demographic information was collected for each patient, including surgical variables. Radiographic parameters and patient reported outcome measures (PROMs) including ODI, VAS back and leg, and ZCQ were assessed preoperatively and at 6 weeks, 3 months, 6 months, and 12 months postoperatively. Adverse event, complication and reoperation data were also collected for each patient. <h3>RESULTS</h3> At the time of this study, 153 patients had undergone implantation of the TOPS device as part of this ongoing clinical trial and were included in this study. The mean surgical time was 187.8 minutes and mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean ODI, VAS leg and back, and ZCQ scores improved significantly at all postoperative time points (P>0.001). Greater than 79% of patients achieved MCID in all patient reported outcome measures at all postoperative time points. There were no clinically significant changes in radiographic parameters and all operative segments remained mobile at 1-year follow-up without evidence of worsening sagittal translation. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device, including two new neurological deficits, two dural tears, two retained drains, one misplaced pedicle screw, one screw loosening, one infection, one seroma and one hematoma. Nine patients (5.9%) underwent a total of 13 reoperations, eight for surgical complications (5.3%) and one (0.6%) of which was for device-related failure due to bilateral L4 pedicle screw loosening. <h3>CONCLUSIONS</h3> Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all PROMs and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate. <h3>FDA DEVICE/DRUG STATUS</h3> Total Posterior Spine System (TOPS) device: Investigational.
Published Version
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