Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis

Domagoj Coric; Ahmad Nassr; Paul K. Kim; William C. Welch; Stephen Robbins; Steven DeLuca; Donald Whiting; Ali Chahlavi; Stephen M. Pirris; Michael W. Groff; John H. Chi; Jason H. Huang; Roland Kent; Robert G. Whitmore; Scott A. Meyer; Paul M. Arnold; Ashvin I. Patel; R. Douglas Orr; Ajit Krishnaney; Peggy Boltes; Yoram Anekstein; Michael P. Steinmetz

doi:10.3171/2022.7.SPINE22536

Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis

Domagoj Coric, Ahmad Nassr, Paul K. Kim, William C. Welch, Stephen Robbins, Steven DeLuca, Donald Whiting, Ali Chahlavi, Stephen M. Pirris, Michael W. Groff, John H. Chi, Jason H. Huang, Roland Kent, Robert G. Whitmore, Scott A. Meyer, Paul M. Arnold, Ashvin I. Patel, R. Douglas Orr, Ajit Krishnaney, Peggy BoltesYoram Anekstein, Michael P. Steinmetz

Research output: Contribution to journal › Article › peer-review

Abstract

OBJECTIVE The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4–5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85^◦) to 24 months (3.86^◦). CONCLUSIONS This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

Original language	English (US)
Pages (from-to)	115-125
Number of pages	11
Journal	Journal of Neurosurgery: Spine
Volume	38
Issue number	1
DOIs	https://doi.org/10.3171/2022.7.SPINE22536
State	Published - Jan 2023
Externally published	Yes

Keywords

TOPS device
degenerative spondylolisthesis
motion preservation
posterior lumbar arthroplasty

ASJC Scopus subject areas

Clinical Neurology
Neurology
Surgery

Online availability

10.3171/2022.7.SPINE22536

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Coric, D., Nassr, A., Kim, P. K., Welch, W. C., Robbins, S., DeLuca, S., Whiting, D., Chahlavi, A., Pirris, S. M., Groff, M. W., Chi, J. H., Huang, J. H., Kent, R., Whitmore, R. G., Meyer, S. A., Arnold, P. M., Patel, A. I., Orr, R. D., Krishnaney, A., ... Steinmetz, M. P. (2023). Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis. Journal of Neurosurgery: Spine, 38(1), 115-125. https://doi.org/10.3171/2022.7.SPINE22536

Coric, D, Nassr, A, Kim, PK, Welch, WC, Robbins, S, DeLuca, S, Whiting, D, Chahlavi, A, Pirris, SM, Groff, MW, Chi, JH, Huang, JH, Kent, R, Whitmore, RG, Meyer, SA, Arnold, PM, Patel, AI, Orr, RD, Krishnaney, A, Boltes, P, Anekstein, Y & Steinmetz, MP 2023, 'Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis', Journal of Neurosurgery: Spine, vol. 38, no. 1, pp. 115-125. https://doi.org/10.3171/2022.7.SPINE22536

@article{be783570dbdc46e294d7765b71c04b5f,

title = "Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis",

abstract = "OBJECTIVE The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4–5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85◦) to 24 months (3.86◦). CONCLUSIONS This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.",

keywords = "TOPS device, degenerative spondylolisthesis, motion preservation, posterior lumbar arthroplasty",

author = "Domagoj Coric and Ahmad Nassr and Kim, {Paul K.} and Welch, {William C.} and Stephen Robbins and Steven DeLuca and Donald Whiting and Ali Chahlavi and Pirris, {Stephen M.} and Groff, {Michael W.} and Chi, {John H.} and Huang, {Jason H.} and Roland Kent and Whitmore, {Robert G.} and Meyer, {Scott A.} and Arnold, {Paul M.} and Patel, {Ashvin I.} and Orr, {R. Douglas} and Ajit Krishnaney and Peggy Boltes and Yoram Anekstein and Steinmetz, {Michael P.}",

note = "tion trial. The study sites received financial support for participating in the study from Premia Spine. Dr. Coric: stock ownership in Premia Spine; consultant for Premia Spine, Spine Wave, Globus Medical, Medtronic, Integrity Implants, SpineArt, and NuVasive; funding to institution for this study from Premia Spine; and royalties from Spine Wave, Globus Medical, Medtronic, Integrity Implants, Stryker Spine, and Surgalign. Dr. Nassr: research funding to institution from Premia Spine and 3Spine; and fellowship funding to institution from AO Spine NA. Dr. Robbins: stock ownership in Premia Spine; and consultant for Surgalign, Curasan, and Innovasis. Dr. DeLuca: consultant for Premia Spine, CTL Amedica, and Spineology; research funding from Premia Spine; and advisory board for Cerapedics. Dr. Pirris: advisory panel for Cerapedics; consultant for MedCyclops; and stock ownership in Nexsis and ORHub. Dr. Groff: royalties from SpineArt and NuVasive; and consultant for Bioventus and Nanohive. Dr. Chi: consultant for DePuy Spine and Stryker Spine. Dr. Whitmore: consultant for DePuy Synthes Spine and Intrinsic Therapeutics; and stockholder with OnPoint Surgical. Dr. Meyer: consultant for Stryker and Globus. Dr. Patel: consultant for Centinel Spine and NuVasive. Dr. Orr: consultant for Stryker Spine. Dr. Krishnaney: consultant for Stryker. Dr. Anekstein: consultant for and stock options from Premia Spine. Dr. Steinmetz: royalties from Globus, Zimmer/Biomet, and Else-vier; consultant for Globus and Cerapedics; and honorarium from Globus. We thank the other TOPS Study Group investigators for their contributions to the study: Arjun Sebastian, MD, and Brett Freedman, MD (Mayo Clinic); Kent New, MD (St. Vincent{\textquoteright}s Jacksonville); Alain Fabi, MD (Bronson Neuroscience); David Tahernia, MD (Eisenhower Medical); Vivek Kushwaha, MD (Orthopaedic Associates Houston); Faheem Sandhu, MD, and Bobby Kalantar, MD (Georgetown Medical Center); Nick Phan, MD (Cabell Huntington Hospital); Eric Potts, MD, Jean-Pierre Mobasser, MD, and Saad Khairi, MD (Goodman Campbell); Andy Kranenburg, MD (Providence Medford); James Zucherman, MD, and Ken Hsu, MD (Dignity St. Mary{\textquoteright}s); Neel Anand, MD, Eli Baron, MD, Jason Cuellar, MD, and Chris Kong, MD (Cedars-Sinai); Harel Deutsch, MD (Rush Presbyterian); Scott Webb, DO (Florida Spine Institute); Joshua Wind, MD, and Joshua Ammerman, MD (Sibley-Hopkins); Vikas Patel, MD, and Eve Burger, MD (University of Colorado); Ted Belanger, MD (Texas Back Institute); Jared Ament, MD (Adventist Glendale); Alan Villavicencio, MD (Boulder Neurosurgical); Mitch Levine, MD, Jon Oren, MD, and David Langer, MD (Lenox Hill); Michael Oh, MD (UC Irvine); Mark Oppenlander, MD, and Osama Kashlan, MD (University of Michigan); Joseph Cheng, MD (University of Cincinnati); Mark Gerber, MD (NASA Neuroscience); and Jim Lindley, MD (Memorial Spine Savannah).",

year = "2023",

month = jan,

doi = "10.3171/2022.7.SPINE22536",

language = "English (US)",

volume = "38",

pages = "115--125",

journal = "Journal of Neurosurgery: Spine",

issn = "1547-5654",

publisher = "American Association of Neurological Surgeons",

number = "1",

}

TY - JOUR

T1 - Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis

AU - Coric, Domagoj

AU - Nassr, Ahmad

AU - Kim, Paul K.

AU - Welch, William C.

AU - Robbins, Stephen

AU - DeLuca, Steven

AU - Whiting, Donald

AU - Chahlavi, Ali

AU - Pirris, Stephen M.

AU - Groff, Michael W.

AU - Chi, John H.

AU - Huang, Jason H.

AU - Kent, Roland

AU - Whitmore, Robert G.

AU - Meyer, Scott A.

AU - Arnold, Paul M.

AU - Patel, Ashvin I.

AU - Orr, R. Douglas

AU - Krishnaney, Ajit

AU - Boltes, Peggy

AU - Anekstein, Yoram

AU - Steinmetz, Michael P.

N1 - tion trial. The study sites received financial support for participating in the study from Premia Spine. Dr. Coric: stock ownership in Premia Spine; consultant for Premia Spine, Spine Wave, Globus Medical, Medtronic, Integrity Implants, SpineArt, and NuVasive; funding to institution for this study from Premia Spine; and royalties from Spine Wave, Globus Medical, Medtronic, Integrity Implants, Stryker Spine, and Surgalign. Dr. Nassr: research funding to institution from Premia Spine and 3Spine; and fellowship funding to institution from AO Spine NA. Dr. Robbins: stock ownership in Premia Spine; and consultant for Surgalign, Curasan, and Innovasis. Dr. DeLuca: consultant for Premia Spine, CTL Amedica, and Spineology; research funding from Premia Spine; and advisory board for Cerapedics. Dr. Pirris: advisory panel for Cerapedics; consultant for MedCyclops; and stock ownership in Nexsis and ORHub. Dr. Groff: royalties from SpineArt and NuVasive; and consultant for Bioventus and Nanohive. Dr. Chi: consultant for DePuy Spine and Stryker Spine. Dr. Whitmore: consultant for DePuy Synthes Spine and Intrinsic Therapeutics; and stockholder with OnPoint Surgical. Dr. Meyer: consultant for Stryker and Globus. Dr. Patel: consultant for Centinel Spine and NuVasive. Dr. Orr: consultant for Stryker Spine. Dr. Krishnaney: consultant for Stryker. Dr. Anekstein: consultant for and stock options from Premia Spine. Dr. Steinmetz: royalties from Globus, Zimmer/Biomet, and Else-vier; consultant for Globus and Cerapedics; and honorarium from Globus. We thank the other TOPS Study Group investigators for their contributions to the study: Arjun Sebastian, MD, and Brett Freedman, MD (Mayo Clinic); Kent New, MD (St. Vincent’s Jacksonville); Alain Fabi, MD (Bronson Neuroscience); David Tahernia, MD (Eisenhower Medical); Vivek Kushwaha, MD (Orthopaedic Associates Houston); Faheem Sandhu, MD, and Bobby Kalantar, MD (Georgetown Medical Center); Nick Phan, MD (Cabell Huntington Hospital); Eric Potts, MD, Jean-Pierre Mobasser, MD, and Saad Khairi, MD (Goodman Campbell); Andy Kranenburg, MD (Providence Medford); James Zucherman, MD, and Ken Hsu, MD (Dignity St. Mary’s); Neel Anand, MD, Eli Baron, MD, Jason Cuellar, MD, and Chris Kong, MD (Cedars-Sinai); Harel Deutsch, MD (Rush Presbyterian); Scott Webb, DO (Florida Spine Institute); Joshua Wind, MD, and Joshua Ammerman, MD (Sibley-Hopkins); Vikas Patel, MD, and Eve Burger, MD (University of Colorado); Ted Belanger, MD (Texas Back Institute); Jared Ament, MD (Adventist Glendale); Alan Villavicencio, MD (Boulder Neurosurgical); Mitch Levine, MD, Jon Oren, MD, and David Langer, MD (Lenox Hill); Michael Oh, MD (UC Irvine); Mark Oppenlander, MD, and Osama Kashlan, MD (University of Michigan); Joseph Cheng, MD (University of Cincinnati); Mark Gerber, MD (NASA Neuroscience); and Jim Lindley, MD (Memorial Spine Savannah).

PY - 2023/1

Y1 - 2023/1

N2 - OBJECTIVE The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4–5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85◦) to 24 months (3.86◦). CONCLUSIONS This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

AB - OBJECTIVE The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4–5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85◦) to 24 months (3.86◦). CONCLUSIONS This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

KW - TOPS device

KW - degenerative spondylolisthesis

KW - motion preservation

KW - posterior lumbar arthroplasty

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Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis

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