A Pivotal Study of the Premia Spine TOPS™ System

Completed · Not applicable

Conditions studied: Lumbar Spinal Stenosis, Degenerative Spondylolisthesis

In brief

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.

Key facts

Study ID: NCT03012776
Run by: Premia Spine
People needed: 305
Starts: 2017-07-17
Expected to finish: 2023-06-14
Last updated by the study team: 2024-06-17

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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;
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;

Where it is running

Adventist Health Glendale — Glendale, California, United States
Cedars Sinai — Los Angeles, California, United States
University of California - Irvine Medical Center — Orange, California, United States
Eisenhower Desert Orthopedic Center — Palm Desert, California, United States
St. Mary's Medical Center, Spine Center — San Francisco, California, United States
University of Colorado — Aurora, Colorado, United States
Boulder Neurosurgical & Spine Associates — Boulder, Colorado, United States
Georgetown University Hospital — Washington D.C., District of Columbia, United States
Sibley Hospital/Johns Hopkins — Washington D.C., District of Columbia, United States
Florida Spine Institute — Clearwater, Florida, United States
St. Vincent's Spine & Brain Institute — Jacksonville, Florida, United States
Physicians Regional Medical Center — Naples, Florida, United States
Kennedy White Orthopedic Center — Sarasota, Florida, United States
Memorial Health University Medical Center — Savannah, Georgia, United States
Rush University Medical Center — Chicago, Illinois, United States
Carle Foundation Hospital — Urbana, Illinois, United States
Goodman Campbell Brain & Spine — Carmel, Indiana, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Lahey Clinic — Burlington, Massachusetts, United States
University of Michigan Medical Center — Ann Arbor, Michigan, United States
Bronson Neuroscience Center — Kalamazoo, Michigan, United States
Mayo Clinic — Rochester, Minnesota, United States
Lenox Hill Hospital — New York, New York, United States
Carolina Neurosurgery & Spine Associates, P.A. — Charlotte, North Carolina, United States
Univ. of Cincinnati Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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