A Pivotal Study of the Premia Spine TOPS™ System

A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lumbar Spinal Stenosis; Degenerative Spondylolisthesis
• Intervention / Treatment: Device: Total Posterior Spine System (TOPS); Procedure: Transforaminal Lumbar Interbody Fusion (TLIF)

Detailed Description

Degenerative spine disease is a normal part of the aging process and can cause pain and significantly limit normal movement. The most commonly diagnosed condition is Lumbar Spinal Stenosis (LSS) which presents with pain, and often weakness or numbness in the buttocks and/or lower extremities that is worsened with standing and walking. For patients that do not respond to conservative treatment decompressive surgery is indicated. When LSS is accompanied by a diagnosis of degenerative spondylolisthesis, fusion of the affected segment is often added to prevent progression of the instability that may accompany the removal of bony elements as part of the decompression. While decompression and fusion have been shown to significantly improve patient outcomes, when compared to decompression alone, fusion has been associated with several comorbidities such as adjacent level degeneration and pseudoarthrosis.

The TOPS System was designed as an alternative to fusion and is a motion preserving posterior spine implant designed to provide dynamic stabilization to a single lumbar spine segment following decompression surgery.

Patients meeting all of the entry criteria will be randomized (2:1) to receive either the TOPS System or TLIF following decompression surgery. Patients will be followed for 5 years and the composite primary endpoint will be assessed at 2 years following index surgery.

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Adventist Health Glendale
    • Los Angeles, California, United States, 90048
      • Cedars Sinai
    • Orange, California, United States, 92868
      • University of California - Irvine Medical Center
    • Palm Desert, California, United States, 92270
      • Eisenhower Desert Orthopedic Center
    • San Francisco, California, United States, 94117
      • St. Mary's Medical Center, Spine Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Boulder, Colorado, United States, 80303
      • Boulder Neurosurgical & Spine Associates
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital
    • Washington, District of Columbia, United States, 20016
      • Sibley Hospital/Johns Hopkins
  • Florida
    • Clearwater, Florida, United States, 33765
      • Florida Spine Institute
    • Jacksonville, Florida, United States, 32216
      • St. Vincent's Spine & Brain Institute
    • Naples, Florida, United States, 34119
      • Physicians Regional Medical Center
    • Sarasota, Florida, United States, 34232
      • Kennedy White Orthopedic Center
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Memorial Health University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hospital
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Goodman Campbell Brain & Spine
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Medical Center
    • Kalamazoo, Michigan, United States, 49007
      • Bronson Neuroscience Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolina NeuroSurgery & Spine Associates, P.A.
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Univ. of Cincinnati Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oregon
    • Medford, Oregon, United States, 97504
      • Southern Oregon Orthopedics
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17011
      • Orthopedic Institute of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19106
      • UPENN Health Systems Department of Neurosurgery
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network
  • Texas
    • Bellaire, Texas, United States, 77401
      • Orthopaedic Associates
    • Plano, Texas, United States, 75093
      • Texas Back Institute
    • Temple, Texas, United States, 76508
      • Baylor Scott & White
  • Virginia
    • Richmond, Virginia, United States, 23229
      • Neurosurgical Associates, P.C.
  • West Virginia
    • Huntington, West Virginia, United States, 25755
      • Marshall University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53212
      • Wisconsin Bone and Joint S.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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;

  1. Degenerative spondylolisthesis or retrolisthesis up to Grade I, as determined by the investigator based on flexion/extension X-rays,
  2. 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,
  3. 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);

Exclusion Criteria:

• 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;
• AIDS, HIV, Rheumatoid arthritis or other autoimmune disease;
• Tuberculosis - active or in the past 3 years;
• Active malignancy;
• Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study;
• Cauda equina syndrome or neurogenic bowel/bladder dysfunction;
• Vascular claudication due to severe arterial insufficiency of the legs;
• Sustained pathologic lumbar fractures of the vertebra or multiple lumbar fractures of the vertebra or hip;
• Significant peripheral neuropathy causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities;
• Insulin-dependent diabetes mellitus;
• Immunologically suppressed, receiving steroids > 1 month out of the past year;
• Current chemical/alcohol dependency;
• Current smoker or user of tobacco products;
• Pregnant or interested in becoming pregnant;
• Currently involved in active spinal litigation;
• Currently having a workman's compensation claim;
• Currently incarcerated;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOPS System; Investigational surgical treatment using TOPS System	Device: Total Posterior Spine System (TOPS); Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis
Active Comparator: Transforaminal Lumbar Interbody Fusion (TLIF); Control surgical treatment using interbody fusion and placement of posterolateral instrumentation	Procedure: Transforaminal Lumbar Interbody Fusion (TLIF); Fusion with placement of interbody cage and posterolateral instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Premia Spine

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): June 27, 2022
• Study Completion (Anticipated): June 1, 2027

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: CL-2830 - US IDE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes