An Interventional Multi-Center investigation of Single Level Transforaminal Lumber Interbody Fusion (TLIF) Stabilized with Pedicle Screws

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Symptomatic Lumbar Degeneration
  • Age: Between 21 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy
    2. Subject have primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar spine
    3. Exhausted conservative treatment (e.g. bed rest, physical therapy, medications, TENS, manipulation, and/or spinal injections) for at least 3 months or has a neurologic emergency
    4. Preoperative Oswestry Disability Index score > 40/100 at baseline
    5. Preoperative total leg pain and/or total back pain score > 40/100 on the Visual Analog Scale at baseline
    6. Surgical candidate for a posterior approach to the lumbar spine
    7. Psychosocially, mentally, and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms
    8. Provide signed informed consent

You may not be eligible for this study if the following are true:

    1. Individuals with more than one vertebral level requiring treatment;
    2. Previous instrumented surgery at the index lumbar level or an adjacent level
    3. Degenerative or lytic spondylolisthesis greater than Grade 1
    4. Rotatory scoliosis at the index level
    5. Congenital bony and/or spinal cord abnormalities at the index level
    6. Subcaudal defect, disrupting the integrity of the pedicle
    7. Clinically compromised vertebral bodies at the index level due to current or past trauma
    8. Disrupted anterior longitudinal ligament at the index level
    9. Overlying thoracolumbar kyphosis within one level
    10. Back pain of unknown etiology without leg pain
    11. Severe spondylosis
    12. Known allergy to PEEK or titanium
    13. Unable to undergo a CT scan or other radiograph assessments
    14. Osteopenia: All patients will complete SCORE/MORES to screen if a DEXA scan is indicated.
    15. Has history of any endocrine or metabolic disorder known to affect osteogenesis
    16. Insulin-dependent diabetes mellitus
    17. Lactating, pregnant or interested in becoming pregnant in the next 3 years
    18. Active infection – systemic or local
    19. 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
    20. Body Mass Index > 40
    21. Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease
    22. Systemic disease including Lupus disease, Reiter’s disease, Rheumatoid disease, AIDS, HIV, hepatitis or autoimmune disease that requires immunosuppressive therapy, including biologics, for systemic inflammation
    23. Active malignancy
    24. Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes
    25. Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease
    26. Has a Waddell Signs of Inorganic Behavior score of 3 or greater
    27. Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 code
    28. Currently smoking or using tobacco products, including ecigarette products (e.g., vaping)
    29. Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation
    30. Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results
    31. In the opinion of the investigator, the subject has a behavioral, cognitive, social, or medical problem that may interfere with the assessment of the safety or effectiveness of the device
    32. Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.

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