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

Recruiting now · Not applicable

Conditions studied: Radiculopathy Lumbar, Degenerative Lumbar Disc Disease

In brief

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

Key facts

Study ID: NCT07222787
Run by: Providence Medical Technology, Inc.
People needed: 250
Starts: 2025-12-01
Expected to finish: 2029-07-01
Last updated by the study team: 2026-07-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
a) Diagnosis of radiculopathy of the lumbar spine, with pain, including at least one of the following: i) Leg and/or buttock pain, weakness, numbness, or paresthesia ii) Low back pain iii) Neurogenic claudication b) Radiographically determined pathology (CT, MRI, X-rays) at the levels to be treated correlating to primary symptoms including at least one of the following: i) Decreased disc height in comparison to a normal adjacent disc. ii) Degenerative instability ≤ grade 1 spondylolisthesis (<25% slip). iii) Recurrent disc herniation. iv) Central and/or foraminal stenosis.
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
Willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.
Written informed consent provided by subject.

You may not qualify if…

Any disease or condition that, in the investigator's opinion, would preclude accurate radiographic evaluation of any treated vertebrae (e.g. morbid obesity).
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
Fixed or permanent neurologic deficit related to the target treatment levels that cannot be improved with surgery
Leg, buttocks, or back pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention.
Symptomatic disc degeneration requiring surgical intervention at more or less than two levels.
Diagnosis of spondylolisthesis, grade >1.
Diagnosis of lytic spondylolisthesis
Diagnosis of iatrogenic, traumatic, or dysplastic spondylolisthesis
Congenital bony and/or spinal cord abnormalities affecting spinal stability.
Diagnosis of Paget's disease, osteomalacia or any other metabolic bone disease other than osteopenia.
Diagnosis of osteoporosis, defined as a previous DEXA bone density T-score of ≤-2.5.
Active malignancy or a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and without clinical signs or symptoms of the malignancy for at least five years.
Has an uncontrolled seizure disorder.
Cauda equina syndrome or neurogenic bowel/bladder dysfunction;
Use of epidural steroids within 14 days prior to surgery.
A concomitant condition requiring daily, high-dose oral steroids.
High dose steroid use is defined as:
Daily, chronic use of oral steroids of 5 mg/day or greater (steroid inhalers are not exclusionary).
Use of short-term (less than 10 days) oral steroids at a daily dose greater than 40 mg within one month of the study procedure.

Where it is running

Huntsman Spine — Salt Lake City, Utah, United States (enrolling)
HonorHealth Neurology — Scottsdale, Arizona, United States (enrolling)
California Spine — Los Angeles, California, United States (enrolling)
Golden State Orthopedics & Spine — Los Gatos, California, United States (enrolling)
Orthopaedic Spine Institute — Hinsdale, Illinois, United States (enrolling)
Hospital for Special Surgery — New York, New York, United States (enrolling)
American Neurospine Institute — Frisco, Texas, United States (enrolling)
Barrow Brain & Spine — Scottsdale, Arizona, United States (enrolling)
Olympia Neurological Institute — Austin, Texas, United States
Spine Physician Institute — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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