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Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes

Study acronym: ILIF
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study sites: 10 to 12
    • Eligibility criteria expanded, about 25 words
  2. Minor Study sites: 9 to 10v7
  3. Minor Study sites: 8 to 9v6
  4. Minor Trial status changed: Enrolling by Invitation → Recruiting
    • Study sites: 7 to 8
    v5
  5. Minor Trial sites expanded: 4 → 7 locations
    • Study title shortened, about 1 word
    v4
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  1. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 4
    • Start date changed from estimate of Nov 1, 2025 to Dec 1, 2025
    v3
  2. Notable Primary endpoints revised (3)
    • Secondary endpoints revised (4)
    • Study description expanded, about 307 words
    • Study title shortened, about 7 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07222787
Lead Sponsor Providence Medical Technology, Inc.
Conditions
(from sponsor)
Radiculopathy Lumbar, Degenerative Lumbar Disc Disease
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov