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Active Clinical Trials

A Pivotal Study of the Premia Spine TOPS™ System

NCT:
03012776
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Premia Spine
Contact: 

For more information, please contact Jason Sumner at 412-359-6011 or Jason.Sumner@ahn.org

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

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.

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
Eligibility Criteria: 
Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No