3Spine Lumbar Fusion Real World Evidence Study (NCT04823858) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
3Spine Lumbar Fusion Real World Evidence Study
United States176 participantsStarted 2021-05-25
Plain-language summary
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).
Who can participate
Age range21 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy;
ā. Subject plans to undergo a one-level Open or Mini-Open TLIF or PLIF procedure (stabilized with pedicle screws) independent of this research protocol;
ā. 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;
ā. 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:
ā. Herniated nucleus pulposus;
ā. Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule;
ā. Spondylosis (defined by the presence of osteophytes);
Exclusion criteria
ā. More than one vertebral level requiring treatment;
ā. Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;
ā. Degenerative or lytic spondylolisthesis greater than Grade 1 (\<25% translation);
ā. Rotatory scoliosis at the level to be treated;
ā. Congenital bony and/or spinal cord abnormalities at the level to be treated;
ā. Subcaudal defect, disrupting the integrity of the pedicle;
ā. 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;
ā. Disrupted anterior longitudinal ligament at the index level;