Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion … (NCT07222787) | Clinical Trial Compass
RecruitingNot Applicable
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
United States250 participantsStarted 2025-12-01
Plain-language summary
The goal of this clinical trial is to assess the safety and effectiveness of the study device, CORUS-LX, as an adjunct to lumbar interbody fusion, when used in combination with pedicle screw and rod constructs for the treatment of lumbosacral degenerative disease in patients requiring 2 level (L4-S1) lumbar fusion, for the treatment of symptomatic degenerative lumbosacral disc disease. The main questions it aims to answer are:
Is there fusion success at the treated posterior anatomy of each level? Is there an absence of major adverse device related events? Is there an absence of injections (steroid, facet joint, nerve block) or subsequent revision surgery at index levels for symptoms related to back or leg pain?
Researchers will compare a control arm to the treatment arm to see if research results vary from standard minimally invasive supplemental posterior fusion.
Eligible participants will undergo one of the below interventions:
* Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with supplemental posterior fusion performed using the study device, including pedicle screw and rod fixation.
* Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with standard minimally invasive supplemental posterior fusion including pedicle screw and rod fixation.
Participants will also be asked to read, understand, and sign the informed consent, attend a Screening/Baseline visit, undergo surgery for their designated intervention, and participate in 5 additional study visits where they will complete surveys for patient reported outcomes and SOC procedures. These visits will occur at the below intervals (based upon surgery day as day 0):
* 6 weeks
* 3 months
* 6 months
* 12 months
* 24 months
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age 18-80 years (Skeletally Mature)
✓. Indicated for lumbar interbody fusion for treatment of degenerative lumbosacral disease at two contiguous disc levels between L4-S1 as determined by the following:
✓. Oswestry Disability Index Score of \> 40/100 (Severe Disability).
✓. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
✓. At least six weeks from symptom onset; or
✓. Have the presence of progressive symptoms or signs of nerve root/ spinal cord compression despite continued non-operative conservative treatment.
✓. Reported to be medically cleared for surgery.
✓. Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms
Exclusion criteria
✕. Any disease or condition that, in the investigator's opinion, would preclude accurate radiographic evaluation of any treated vertebrae (e.g. morbid obesity).
What they're measuring
1
Proportion of participants with fusion success at the treated posterior anatomy of each level.
Timeframe: 12 months post procedure
2
Proportion of participants with freedom from serious adverse event with definite relationship to treatment devices (interbody or posterior devices).
Timeframe: 12 months post procedure
3
Proportion of Participants with freedom from injections (steroid, facet joint, nerve block) or subsequent revision surgery at index levels for symptoms related to back or leg pain.
✕. Any anatomy or condition that makes posterior fusion treatment infeasible (e.g. fused facets).
✕. Has, in the Investigator's opinion, any disease or condition that would preclude accurate clinical evaluation (e.g. neuromuscular disorders).
✕. Active systemic infection or infection at the operative site.
✕. Anticipated treatment for active systemic infection, including HIV or Hepatitis C.
✕. Previous trauma to any of the L3 to S1 levels resulting in significant bony or disco-ligamentous lumbar spine injury that may prevent device placements.
✕. Prior instrumented surgery or pseudoarthrosis at the operative or adjacent levels.
✕. Indicated for or history of laminectomy at any of the index or adjacent levels