One-year data published in Clinical Spine Surgery found Premia Spine's Tops facet replacement system was effective across all patient-reported outcome measures.
Four things to know:
1. The multicenter FDA study looked at 153 patients who had the Tops device implanted, and 105 of them reached their one-year follow-up time, Premia Spine said in an Oct. 19 news release.
2. Lumbar facet arthroplasty with the device showed a low complication rate, significant improvement in all patient-reported outcomes measures and improvement. Metrics measured included the Mean Oswestry Disability Index, Visual Analog Score and Zurich Claudication questionnaire scores.
3. Postoperative complications occurred in 11 patients, and nine had reoperations for device-related failure.
4. The study concluded: "Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate."