Clinical Trials

Inclusion Criteria:

1. Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy;

2. Subject plans to undergo a one-level Open or Mini-Open TLIF or PLIF procedure
(stabilized with pedicle screws) independent of this research protocol;

3. Subject is to be treated with on-label use of an FDA-cleared TLIF or PLIF cage(s) and
pedicle screw system independent of this research protocol;

4. 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;

5. 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;

6. Preoperative Oswestry Disability Index score >/= 40/100 at baseline;

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 (greater than or equal to 15 degrees) 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 a CT scan or other radiograph assessments;

14. Osteopenia: The SCORE/MORES will be utilized for all females age <50 and males age <55
to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is
required. A DEXA scan is indicated for all females age ≥50 and all males age ≥55. 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); (Use within 30 days of surgery date is considered 'current');

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 03/01/2024. Questions regarding updates should be directed to the study team contact.