A Pivotal Study of the Premia Spine TOPS™ System
Completed · Not applicable · NCT03012776
Conditions: Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
At a glance
- Research payments reported, 2025
- $510,229
- U.S. investigators named
- 26
- Sites paid
- 27
- Planned or actual enrollment
- 305
About the trial
- Sponsor
- Premia Spine
- Tested
- Total Posterior Spine System (TOPS) (device), Transforaminal Lumbar Interbody Fusion (TLIF) (procedure)
- Dates
- Started 2017-07-17; completion 2023-06-14
- Results posted
- Not yet
The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint capsule. Success will be assessed by means of a composite endpoint that measures improvement in in patient reported outcomes and the absence of any major device related complications.
From ClinicalTrials.gov, last updated 2024-06-17. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Premia Spine, Ltd. reported $510,229 in research payments for this study in 2025 (72 payments).
Products named: Tops
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Neel Anand, M.D. Spine Surgery · Los Angeles, CA
- Michael Y. Oh, MD Neurosurgery · Orange, CA
- Amir D. Tahernia, M.D. Spine Surgery · Rancho Mirage, CA
- Alan T. Villavicencio, MD Neurosurgery · Longmont, CO
- Harel Deutsch, MD Neurosurgery · South Miami, FL
- Mark B. Gerber, M.D. Neurosurgery · Naples, FL
- Roland S. Kent, MD Spine Surgery · Post Falls, ID
- Suguna Pappu, MD Neurosurgery · Maywood, IL
- Eric A. Potts, MD Neurosurgery · Carmel, IN
- John H. Chi, MD Neurosurgery · Boston, MA
- Robert G. Whitmore, MD Neurosurgery · Burlington, MA
- Faheem A. Sandhu, M.D. Neurosurgery · Clinton, MD
- Gregory C. Wiggins, M.D. Neurosurgery · Kalamazoo, MI
- Ahmad Nassr, MD Orthopedic Surgery · Rochester, MN
- Jonathan M. Parish, MD Neurosurgery · Charlotte, NC
- Scott A. Meyer, M.D. Neurosurgery · Morristown, NJ
- Joseph Cheng, MD Neurosurgery · Cincinnati, OH
- Michael P. Steinmetz, MD Neurosurgery · Cleveland, OH
- Andy J. Kranenburg, M.D. Spine Surgery · Medford, OR
- Tyson P. Maugle, D.O. Orthopedic Surgery · Camp Hill, PA
- William C. Welch, MD Neurosurgery · Philadelphia, PA
- Donald M. Whiting, MD Neurosurgery · Washington, PA
- Jason H. Huang, MD Neurosurgery · Temple, TX
- Vivek Kushwaha, M.D. Spine Surgery · Houston, TX
- Stephen E. Robbins, MD Orthopedic Surgery · Glendale, WI
- Nicolas Phan, M.D. Neurosurgery · Huntington, WV
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Mayo Clinic Hospital Rochester, MN $103,169
- Cleveland Clinic, OH $47,694
- Medstar Georgetown University Hospital, DC $45,115
- Carolina Neurosurgery and Spine Associates $41,388
- Brigham and Women's Hospital, MA $38,189
- Hospital of Univ of Pennsylvania, PA $32,994
- Baylor Scott & White Research Institute $32,331
- Orthopaedic Associates LLP $19,839
- Bronson Methodist Hospital, MI $18,287
- The Neurosurgery Foundation at Goodman Campbell $15,979
- Northwest Specialty Hospital $13,950
- Justin PArker Neurological Institute $13,906
- Rush University Medical Center, IL $13,487
- University Physcians and Surgeons dba Marshall Health $13,390
- Wisconsin Bone and Joint $11,154
- Eisenhower Medical Center, CA $8,285
- University of Cincinnati Physicians $7,987
- Carle Foundation Hospital, IL $7,151
- Allegheny Singer Research Institute $5,537
- Morristown Medical Center, NJ $5,511
- Cedars-Sinai Medical Center, CA $4,160
- Uci Health-Orange, CA $3,500
- Southern Oregon Orthopedic Inc $2,419
- Orthopedic Institute of Pennsylvnia $2,272
- $1,500
- Neurosciences and Spine Associates $700
- Lahey Hospital & Medical Center, Burlington, MA $337
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.