A Pivotal Study of the Premia Spine TOPS™ System
A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System
1 other identifier
interventional
305
1 country
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2017
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedStudy Start
First participant enrolled
July 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2023
CompletedJune 17, 2024
June 1, 2024
4.9 years
January 4, 2017
June 13, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
Improvement in Oswestry Disability Index (ODI)
24 months
Maintenance or improvement in Neurological status as assessed by a standard neurological exam performed by Investigator
24 months
No epidural steroid injection, facet joint injection, nerve block, or placement of spinal cord stimulator
24 months
No subsequent surgical intervention
24 months
Radiographic confirmation of fusion in control arm and non-fusion in the TOPS arm
24 months
Absence of any major device related adverse event
24 months
Secondary Outcomes (3)
Greater range-of-motion through flexion-extension
24 months
Improvement (20 mm) in visual analogue scale (VAS) for back pain and worst leg
24 months
Reduction in physical component score on SF-12
24 months
Study Arms (2)
TOPS System
EXPERIMENTALInvestigational surgical treatment using TOPS System
Transforaminal Lumbar Interbody Fusion (TLIF)
ACTIVE COMPARATORControl surgical treatment using interbody fusion and placement of posterolateral instrumentation
Interventions
Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis
Fusion with placement of interbody cage and posterolateral instrumentation
Eligibility Criteria
You may qualify if:
- Be between 35 and 80 years of age;
- Must demonstrate at a single level to be treated (L2/3, L3/4 or L4/5) all three of the following;
- Degenerative spondylolisthesis or retrolisthesis up to Grade I, as determined by the investigator based on flexion/extension X-rays,
- At least moderate lumbar spinal stenosis, defined as at least a 25% reduction in either the central canal, the lateral recess space, and/or the foramen when compared to an adjacent level, as determined by the investigator based on MRI,
- Thickening of the ligamentum flavum and/or scarring of the facet joint capsule as identified by the investigator based on MRI.
- Have had at least six (6) months of failed conservative treatment prior to surgery (e.g., physical therapy, use of anti-inflammatory medications at maximum recommended dosage; administration of epidural/facet injections and/or nerve block);
- Have an Oswestry Disability Index (ODI) score of at least 40/100 at baseline;
- Have leg pain with a VAS score of at least 40/100 for at least one leg at baseline ;
- Lower back pain with a VAS score of at least 10 points less than Worst Leg VAS score;
- Neurogenic claudication (as defined by worsening leg pain when walking or standing, which is reduced when sitting or bending forward);
You may not qualify if:
- Presence of free fragment disc herniation at the index level or either adjacent level;
- Less than 4mm of disc height at the index level;
- Spondylolisthesis greater than Grade I;
- Back or non-radicular leg pain of unknown etiology;
- Stenosis caused by an extruded spinal disc fragment (e.g., herniation) or where the etiology is considered to be congenital, iatrogenic, post-traumatic, or metabolic;
- Known allergy or sensitivity to PEEK, titanium, cobalt chrome, and/or polyurethane;
- Prior surgery at any lumbar vertebral level with instrumentation;
- Prior surgery at the index or adjacent lumbar vertebral level;
- Clinically compromised vertebral bodies at the affected level;
- Scoliosis greater than ten (10) degrees by major Cobb angle;
- BMI \> 40;
- Osteoporosis;
- Paget's disease, gout, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder and/or other metabolic bone disease;
- Active infection - systemic or local;
- Active hepatitis;
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Premia Spinelead
Study Sites (36)
Adventist Health Glendale
Glendale, California, 91206, United States
Cedars Sinai
Los Angeles, California, 90048, United States
University of California - Irvine Medical Center
Orange, California, 92868, United States
Eisenhower Desert Orthopedic Center
Palm Desert, California, 92270, United States
St. Mary's Medical Center, Spine Center
San Francisco, California, 94117, United States
University of Colorado
Aurora, Colorado, 80045, United States
Boulder Neurosurgical & Spine Associates
Boulder, Colorado, 80303, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Sibley Hospital/Johns Hopkins
Washington D.C., District of Columbia, 20016, United States
Florida Spine Institute
Clearwater, Florida, 33765, United States
St. Vincent's Spine & Brain Institute
Jacksonville, Florida, 32216, United States
Physicians Regional Medical Center
Naples, Florida, 34119, United States
Kennedy White Orthopedic Center
Sarasota, Florida, 34232, United States
Memorial Health University Medical Center
Savannah, Georgia, 31405, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Goodman Campbell Brain & Spine
Carmel, Indiana, 46032, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Bronson Neuroscience Center
Kalamazoo, Michigan, 49007, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Carolina Neurosurgery & Spine Associates, P.A.
Charlotte, North Carolina, 28204, United States
Univ. of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Southern Oregon Orthopedics
Medford, Oregon, 97504, United States
Orthopedic Institute of Pennsylvania
Harrisburg, Pennsylvania, 17011, United States
UPENN Health Systems Department of Neurosurgery
Philadelphia, Pennsylvania, 19106, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212, United States
Orthopaedic Associates
Bellaire, Texas, 77401, United States
Texas Back Institute
Plano, Texas, 75093, United States
Baylor Scott & White
Temple, Texas, 76508, United States
Neurosurgical Associates, P.C.
Richmond, Virginia, 23229, United States
Marshall University
Huntington, West Virginia, 25755, United States
Wisconsin Bone and Joint S.C.
Milwaukee, Wisconsin, 53212, United States
Related Publications (1)
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. Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis. J Neurosurg Spine. 2022 Sep 23;38(1):115-125. doi: 10.3171/2022.7.SPINE22536. Print 2023 Jan 1.
PMID: 36152329DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2017
First Posted
January 6, 2017
Study Start
July 17, 2017
Primary Completion
June 27, 2022
Study Completion
June 14, 2023
Last Updated
June 17, 2024
Record last verified: 2024-06