Actively Recruiting
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
Led by Providence Medical Technology, Inc. · Updated on 2026-05-01
250
Participants Needed
8
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years, skeletally mature
- Diagnosed with degenerative lumbosacral disease at two contiguous disc levels between L4 and S1
- Symptoms include lumbar radiculopathy with leg or buttock pain, weakness, numbness, paresthesia, low back pain, or neurogenic claudication
- Radiographic evidence of pathology at treated levels such as decreased disc height, grade 1 or less spondylolisthesis, recurrent disc herniation, or stenosis
- Oswestry Disability Index score above 40/100 indicating severe disability
- Unresponsive to at least six weeks of non-operative conservative treatment or have progressive nerve symptoms despite treatment
- Medically cleared for surgery
- Physically and mentally able and willing to comply with study protocol and complete required forms
- Willing to attend scheduled follow-up visits
- Provided written informed consent
You will not qualify if you...
- Conditions preventing accurate radiographic evaluation (e.g., morbid obesity)
- Anatomy or condition making posterior fusion infeasible (e.g., fused facets)
- Diseases or conditions preventing accurate clinical evaluation (e.g., neuromuscular disorders)
- Active systemic or operative site infection
- Anticipated treatment for systemic infection including HIV or Hepatitis C
- Previous trauma causing significant injury at L3 to S1 levels preventing device placement
- Prior instrumented surgery or pseudoarthrosis at operative or adjacent levels
- History or indication for laminectomy at index or adjacent levels
- Fixed or permanent neurologic deficit at treatment levels not improvable by surgery
- Pain without other symptoms justifying surgery
- Disc degeneration requiring surgery at more or less than two levels
- Grade greater than 1 or other types of spondylolisthesis
- Congenital spinal abnormalities affecting stability
- Metabolic bone diseases other than osteopenia, including osteoporosis (T-score ≤ -2.5)
- Active or recent invasive malignancy unless cured for at least five years
- Uncontrolled seizure disorder
- Cauda equina syndrome or neurogenic bowel/bladder dysfunction
- Use of epidural steroids within 14 days prior to surgery
- Daily high-dose oral steroids or recent short-term high-dose steroids
- Long-term opioid use exceeding 120 mg morphine equivalents
- Known allergy to titanium
- Recent history of substance abuse requiring treatment
- Pregnant, nursing, or planning pregnancy within three years
- Participation in other clinical studies within 30 days prior to surgery
- Pending litigation related to spinal injury
- Anticipated relocation over 50 miles interfering with follow-up
- Mental illness or vulnerable populations compromising consent or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Barrow Brain & Spine
Scottsdale, Arizona, United States, 85251
Actively Recruiting
2
HonorHealth Neurology
Scottsdale, Arizona, United States, 85251
Actively Recruiting
3
California Spine
Los Angeles, California, United States, 90033
Actively Recruiting
4
Orthopaedic Spine Institute
Hinsdale, Illinois, United States, 60521
Actively Recruiting
5
Olympia Neurological Institute
Austin, Texas, United States, 78745
Not Yet Recruiting
6
Spine Physician Institute
Dallas, Texas, United States, 75234
Actively Recruiting
7
American Neurospine Institute
Frisco, Texas, United States, 75033
Not Yet Recruiting
8
Huntsman Spine
Salt Lake City, Utah, United States, 84124
Actively Recruiting
Research Team
E
Erik M Summerside, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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