@article{e01ead7cec534e2cae04e7d87447a861,
title = "A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study",
abstract = "Study Design: Prospective randomized Food and Drug Administration investigational device exemption clinical trial. Objective: The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device. Summary of Background Data: Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty. Methods: Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient. Results: At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points (P>0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening. Conclusions: 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.",
keywords = "ODI, TOPS, VAS, Zurich Claudication Questionnaire, lumbar facet arthroplasty, spondylolisthesis, total posterior spine system",
author = "Pinter, {Zachariah W.} and Freedman, {Brett A.} and Ahmad Nassr and Sebastian, {Arjun S.} and Domagoj Coric and Welch, {William C.} and Steinmetz, {Michael P.} and Robbins, {Stephen E.} and Jared Ament and Neel Anand and Paul Arnold and Eli Baron and Jason Huang and Robert Whitmore and Donald Whiting and David Tahernia and Faheem Sandhu and Ali Chahlavi and Joseph Cheng and John Chi and Stephen Pirris and Michael Groff and Alain Fabi and Scott Meyer and Vivek Kushwaha and Roland Kent and Steven Deluca and Yossi Smorgick and Yoram Anekstein",
note = "Funding Information: The authors have no financial or other influential relationships to disclose. Funding for the ongoing FDA-approved investigational device exemption trial is provided by Premia Spine. Funding Information: ACKNOWLEDGMENTS The authors thank the surgeons of TOPS Study Investigator Group for their contribution to the study: Joshua Ammerman; Joshua Wind (Sibley Memorial Hospital); Neel Anand (Cedars-Sinai Medical Center Los Angeles); Theodore Belanger; Akwasi Boah (Texas Back Institute); Harel Deutsch (Rush University Medical Center); Mark Gerber (Neuroscience and Spine Associates); Ken Hsu, James Zucherman (St. Mary's Medical Center San Francisco); Babak Kalantar (MedStar Georgetown University Hospital); Christopher Kong (Cedars-Sinai Medical Center); Andy Kranenburg (Southern Oregon Orthopedics); Ajit Krishnaney; Douglas Orr (Cleveland Clinic Foundation); Mitchell Levine; Jonathon Oren (Lenox Hill Hospital); James Lindley (Memorial University Medical Center Savannah); Kent New (Ascension St. Vincent's Southside Jacksonville); Michael Oh (University of CA Irvine Medical Center); Mark Oppenlander; Osama Kashlan (University of Michigan); Ashvin Patel (Kennedy-White Orthopaedic Center Sarasota); Vikas Patel; Evalina Burger (University of Colorado); Nick Phan (Marshall Health, Huntington); Eric Potts; Jean-Pierre Mobasser (Goodman Campbell Brain and Spine Indianapolis); Alan Villavicencio; Sharad Rajpal (Boulder Neurosurgical & Spine Associates); Scott Webb (Florida Spine Institute Clearwater); Gregory Wiggins (Bronson Neuroscience Center Kalamazoo); Yizhar Floman (Israel Spine Center); Nathan Lebwohl (University of Miami); and Larry Khoo (The Spine Clinic of Los Angeles). Publisher Copyright: Copyright {\textcopyright} 2022 The Author(s). Published by Wolters Kluwer Health, Inc.",
year = "2023",
month = mar,
day = "1",
doi = "10.1097/BSD.0000000000001365",
language = "English (US)",
volume = "36",
pages = "E59--E69",
journal = "Clinical Spine Surgery",
issn = "2380-0186",
publisher = "Lippincott Williams and Wilkins",
number = "2",
}