A Pivotal Study of the Premia Spine TOPS™ System

This is an interventional treatment trial for Lumbar Spinal Stenosis Read More

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;