3Spine Lumbar Fusion Real World Evidence Study (3STLIF)

  • End date
    Aug 1, 2026
  • participants needed
  • sponsor
Updated on 5 September 2023


This study is designed to collect real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) instrumented with pedicle screws, using the framework of a prospective clinical study (with defined enrollment criteria and pre-specified research follow-up timepoints).


A prospective, multi-center (up to 20), non-blinded study of patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) stabilized with pedicle screws. Investigators will only select those patients who are planned for treatment with on-label use of FDA cleared TLIF/PLIF devices (cage and screw system).

At least 200 subjects with a potential sample size re-estimation at completion. The subjects will return for follow-up at 6-weeks, 3-months, 6-months, and then annually for 5-years post surgery.

Condition Lumbar Spine Degeneration
Treatment Transforaminal Lumbar Interbody Fusion, Transforaminal Lumbar Interbody Fusion, Lumbar Interbody Fusion
Clinical Study IdentifierNCT04823858
Last Modified on5 September 2023


Yes No Not Sure

Inclusion Criteria

Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy
Subject plans to undergo a one-level Open or Mini-Open TLIF or PLIF procedure (stabilized with pedicle screws) independent of this research protocol
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
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
Herniated nucleus pulposus
Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule
Facet joint degeneration/osteophyte formation
Spondylosis (defined by the presence of osteophytes)
Disc degeneration and/or annular degeneration; and/or
Lumbar stenosis defined by spinal cord or nerve root compression
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
Preoperative Oswestry Disability Index score >/= 40/100 at baseline
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
Signed informed consent

Exclusion Criteria

More than one vertebral level requiring treatment
Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level
Degenerative or lytic spondylolisthesis greater than Grade 1 (<25% translation)
Rotatory scoliosis at the level to be treated
Congenital bony and/or spinal cord abnormalities at the level to be treated
Subcaudal defect, disrupting the integrity of the pedicle
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
Disrupted anterior longitudinal ligament at the index level
Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated
Back pain of unknown etiology without leg pain
Severe spondylosis at the level to be treated as characterized by any of the
Autofusion (solid arthrodesis) determined radiographically (CT)
Totally collapsed disc, or
Vertebral body that cannot be mobilized
Unable to undergo a CT scan or other radiograph assessments
Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or
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
vitamin E
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)
Insulin-dependent diabetes mellitus
Lactating, pregnant or interested in becoming pregnant in the next 3 years
Active infection - systemic or local
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
Body Mass Index > 40
Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease
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
Spinal tumor
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
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
Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease
Has a Waddell Signs of Inorganic Behavior score of 3 or greater
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
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
Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation
Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping); (Use within 30 days of surgery date is considered 'current')
Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results
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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