Clinical trial: Investigation of Single-Level Transforaminal Lumber Interbody Fusion (TLIF) Stabilized With Pedicle Screws (NCT04823858)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female, age 21-70 (inclusive) with at least 3 years of life expectancy;

          2. The subject has a primary diagnosis of symptomatic lumbar degeneration with or without
             foraminal or recess stenosis of the lumbar spine at a single level from L1/L2 to L5/S1
             confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more
             than a Grade 1 (<25% translation) spondylolisthesis. Symptomatic lumbar degeneration
             that may be associated with a co-morbid condition such as:

               1. Herniated nucleus pulposus;

               2. Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint
                  capsule;

               3. Facet joint degeneration/osteophyte formation;

               4. Spondylosis (defined by the presence of osteophytes);

               5. Disc degeneration and/or annular degeneration; and/or

               6. Lumbar stenosis defined by spinal cord or nerve root compression;

          3. Exhausted conservative treatment (e.g. bed rest, physical therapy, medications,
             transcutaneous electrical nerve stimulation (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; and

          8. Signed informed consent.

        Exclusion Criteria:

          1. More than one vertebral level requiring treatment;

          2. Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion,
             interspinous device, etc.) at the index lumbar level or an adjacent level;

          3. Degenerative or lytic spondylolisthesis greater than Grade 1 (<25% translation);

          4. Rotatory scoliosis at the level to be treated;

          5. Congenital bony and/or spinal cord abnormalities at the level to be treated;

          6. Subcaudal defect, disrupting the integrity of the pedicle;

          7. Clinically compromised vertebral bodies at the involved level due to current or past
             trauma, e.g., by the radiographic appearance of the fracture callus, malunion or
             nonunion;

          8. Disrupted anterior longitudinal ligament at the index level;

          9. Overlying thoracolumbar kyphosis within one level (includes target and adjacent level)
             of the level to be treated;

         10. Back pain of unknown etiology without leg pain;

         11. Severe spondylosis at the level to be treated as characterized by any of the
             following:

               1. Autofusion (solid arthrodesis) determined radiographically (CT);

               2. Totally collapsed disc, or;

               3. Vertebral body that cannot be mobilized;

         12. Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or
             vitamin E;

         13. Unable to undergo an MRI scan, CT scan or other radiograph assessments;

         14. Osteopenia: All patients will complete SCORES/MORES to screen if a dual energy x-ray
             absorptiometry (DEXA) scan is indicated. If DEXA is required, exclusion will be
             defined as a DEXA bone density measured T score ≤ -1. An existing DEXA is allowed if
             completed within 6 months of subject screening;

         15. Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g.:
             Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis
             imperfecta);

         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. Spinal tumor;

         24. Active malignancy: A patient with a history of any invasive malignancy (except
             non-melanoma skin cancer), unless he/she has been treated with curative intent and
             there have been no clinical signs or symptoms of the malignancy for at least 5 years;

         25. Any degenerative muscular or neurological condition that would interfere with
             evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic
             lateral sclerosis (ALS), or multiple sclerosis;

         26. Has chronic or acute renal and/or hepatic impairment and/or failure or prior history
             of renal and/or hepatic parenchymal disease;

         27. Has a Waddell Signs of Inorganic Behavior score of 3 or greater;

         28. 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;

         29. Current or recent history of chemical/alcohol abuse or dependency using standard
             medical definition of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
             code;

         30. Currently smoking or using tobacco products, including e-cigarette products (e.g.,
             vaping);

         31. Currently pursuing or in active spinal litigation for medical negligence, or trauma,
             or workers compensation;

         32. Is a prisoner, incarcerated, or has been coerced to participate in the study that
             could impact the validity of results;

         33. 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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman

Does the patient match the trial criteria? 0