A Pivotal Study of the Premia Spine TOPS™ System

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 35 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03012776
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Premia Spine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
Additional Details

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.

Arms & Interventions

Arms

Experimental: TOPS System

Investigational surgical treatment using TOPS System

Active Comparator: Transforaminal Lumbar Interbody Fusion (TLIF)

Control surgical treatment using interbody fusion and placement of posterolateral instrumentation

Interventions

Device: - Total Posterior Spine System (TOPS)

Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis

Procedure: - Transforaminal Lumbar Interbody Fusion (TLIF)

Fusion with placement of interbody cage and posterolateral instrumentation

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Adventist Health Glendale, Glendale, California

Status

Recruiting

Address

Adventist Health Glendale

Glendale, California, 91206

Site Contact

[email protected]

Cedars Sinai, Los Angeles, California

Status

Recruiting

Address

Cedars Sinai

Los Angeles, California, 90048

Site Contact

[email protected]

Orange, California

Status

Recruiting

Address

University of California - Irvine Medical Center

Orange, California, 92868

Site Contact

[email protected]

Eisenhower Desert Orthopedic Center, Palm Desert, California

Status

Recruiting

Address

Eisenhower Desert Orthopedic Center

Palm Desert, California,

Site Contact

[email protected]

St. Mary's Medical Center, Spine Center, San Francisco, California

Status

Recruiting

Address

St. Mary's Medical Center, Spine Center

San Francisco, California,

Site Contact

[email protected]

University of Colorado, Aurora, Colorado

Status

Recruiting

Address

University of Colorado

Aurora, Colorado, 80045

Site Contact

[email protected]

Georgetown University Hospital, Washington, District of Columbia

Status

Recruiting

Address

Georgetown University Hospital

Washington, District of Columbia, 20007

Site Contact

[email protected]

Sibley Hospital/Johns Hopkins, Washington, District of Columbia

Status

Recruiting

Address

Sibley Hospital/Johns Hopkins

Washington, District of Columbia, 20016

Site Contact

[email protected]

Florida Spine Institute, Clearwater, Florida

Status

Recruiting

Address

Florida Spine Institute

Clearwater, Florida, 33765

Site Contact

[email protected]

St. Vincent's Spine & Brain Institute, Jacksonville, Florida

Status

Recruiting

Address

St. Vincent's Spine & Brain Institute

Jacksonville, Florida, 32216

Site Contact

[email protected]

Rush University Medical Center, Chicago, Illinois

Status

Not yet recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60612

Site Contact

[email protected]

Carle Foundation Hospital, Urbana, Illinois

Status

Recruiting

Address

Carle Foundation Hospital

Urbana, Illinois, 61801

Site Contact

[email protected]

Brigham and Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts,

Site Contact

[email protected]

Lahey Clinic, Burlington, Massachusetts

Status

Recruiting

Address

Lahey Clinic

Burlington, Massachusetts,

Site Contact

[email protected]

University of Michigan Medical Center, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan Medical Center

Ann Arbor, Michigan, 48109

Site Contact

[email protected]

Bronson Neuroscience Center, Kalamazoo, Michigan

Status

Recruiting

Address

Bronson Neuroscience Center

Kalamazoo, Michigan,

Site Contact

[email protected]

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota,

Site Contact

[email protected]

Lenox Hill Hospital, New York, New York

Status

Recruiting

Address

Lenox Hill Hospital

New York, New York,

Site Contact

[email protected]

Charlotte, North Carolina

Status

Recruiting

Address

Carolina Neurosurgery & Spine Associates, P.A.

Charlotte, North Carolina,

Site Contact

[email protected]

Cleveland Clinic Foundation, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

Site Contact

[email protected]

Southern Oregon Orthopedics, Medford, Oregon

Status

Recruiting

Address

Southern Oregon Orthopedics

Medford, Oregon,

Site Contact

[email protected]

Orthopedic Institute of Pennsylvania, Harrisburg, Pennsylvania

Status

Recruiting

Address

Orthopedic Institute of Pennsylvania

Harrisburg, Pennsylvania,

Site Contact

[email protected]

Philadelphia, Pennsylvania

Status

Recruiting

Address

UPENN Health Systems Department of Neurosurgery

Philadelphia, Pennsylvania,

Site Contact

[email protected]

Allegheny Health Network, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Allegheny Health Network

Pittsburgh, Pennsylvania,

Site Contact

[email protected]

Orthopaedic Associates, Bellaire, Texas

Status

Recruiting

Address

Orthopaedic Associates

Bellaire, Texas, 77401

Site Contact

[email protected]

Texas Back Institute, Plano, Texas

Status

Recruiting

Address

Texas Back Institute

Plano, Texas,

Site Contact

[email protected]

Baylor Scott & White, Temple, Texas

Status

Recruiting

Address

Baylor Scott & White

Temple, Texas,

Site Contact

[email protected]

Marshall University, Huntington, West Virginia

Status

Recruiting

Address

Marshall University

Huntington, West Virginia, 25755

Site Contact

[email protected]

Wisconsin Bone and Joint S.C., Milwaukee, Wisconsin

Status

Recruiting

Address

Wisconsin Bone and Joint S.C.

Milwaukee, Wisconsin, 53212

Site Contact

[email protected]