CORUS-LX System for Degenerative Disc Disease
(ILIF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Erik M Summerside, PhD
Principal Investigator
Providence Medical Technology
Are You a Good Fit for This Trial?
Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Supplemental Posterior Fusion with Standard Technique
- Supplemental Posterior Fusion with Study Device
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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 supplemental posterior fusion including pedicle screw and rod fixation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Providence Medical Technology, Inc.
Lead Sponsor
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