Actively Recruiting
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes for Degenerative Lumbosacral Disc Disease
Led by Providence Medical Technology, Inc. · Updated on 2026-05-29
250
Participants Needed
9
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the CORUS-LX device used alongside lumbar interbody fusion surgery for patients with degenerative lumbosacral disc disease requiring two-level fusion at L4-S1. The study aims to determine if the device improves fusion success, reduces serious device-related events, and lowers the need for additional injections or surgeries related to back or leg pain compared to standard supplemental posterior fusion techniques. Participants will be randomly assigned to one of two groups: one receiving two-level lumbar interbody fusion with standard minimally invasive posterior fusion using pedicle screw and rod fixation, and the other receiving the same fusion with supplemental posterior fusion performed using the CORUS-LX study device. All surgeries will use navigation technology for placing the posterior instrumentation. The study includes a treatment phase with surgery followed by scheduled follow-up visits. Participants will attend a screening and baseline visit, undergo surgery, and then complete five follow-up visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. During these visits, they will complete surveys reporting their outcomes and undergo standard care procedures. Researchers will measure fusion success at treated levels, adverse events related to devices, need for additional injections or surgeries, imaging to assess bone bridging and spinal stability, and patient-reported outcomes over a two-year period.
CONDITIONS
Brief 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
- Indicated for lumbar interbody fusion at two contiguous levels between L4 and S1
- Diagnosed with lumbar radiculopathy causing leg/buttock pain, weakness, numbness, or low back pain
- Radiographic evidence of degenerative disc disease, instability, spondylolisthesis grade ≤1, recurrent herniation, or spinal stenosis
- Oswestry Disability Index score greater than 40/100 indicating severe disability
- Unresponsive to conservative treatment for at least 6 weeks or worsening symptoms despite treatment
- Medically cleared for surgery
- Physically and mentally able to follow the study protocol and complete forms
- Willing to attend scheduled follow-up visits
- Provided written informed consent
You will not qualify if you...
- Conditions preventing accurate radiographic evaluation, such as morbid obesity
- Anatomy or conditions making posterior fusion infeasible, including fused facets
- Neuromuscular disorders or other diseases preventing clinical evaluation
- Active systemic or operative site infection
- Active infections such as HIV or Hepatitis C requiring treatment
- Prior trauma causing significant lumbar spine injury at L3 to S1
- Previous instrumented surgery or pseudoarthrosis at operative or adjacent levels
- History or indication for laminectomy at index or adjacent levels
- Fixed or permanent neurologic deficits unresponsive to surgery
- Pain without radiculopathy symptoms that justifies surgery
- Disc degeneration requiring surgery at more or fewer than two levels
- Spondylolisthesis grade greater than 1, lytic, iatrogenic, traumatic, or dysplastic types
- Congenital bony or spinal cord abnormalities affecting stability
- Metabolic bone diseases other than osteopenia
- Osteoporosis defined by bone density T-score ≤ -2.5
- Active or recent invasive malignancy (except some skin cancers) unless cured for 5 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 doses
- Long-term opioid use greater than 120 mg morphine equivalents daily
- Known allergy to titanium
- Substance abuse requiring treatment within past year
- Pregnant, nursing, or planning pregnancy within 3 years
- Participation in other clinical studies involving devices or drugs within 30 days
- Pending litigation related to spinal injury
- Anticipated relocation over 50 miles interfering with follow-up
- Mental illness or vulnerable status impairing consent or follow-up compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo two-level lumbar interbody fusion at L4-L5 and L5-S1 segments with supplemental posterior fusion using either the study device or standard technique, including pedicle screw and rod fixation with navigation technology.
1 procedure visit and immediate post-operative care
Duration - Up to 24 months after surgery
Participants are monitored for safety and effectiveness outcomes including fusion success, adverse events, and functional recovery.
Approximately 7 to 8 follow-up visits over 24 months
Trial Site Locations
Total: 9 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
Golden State Orthopedics & Spine
Los Gatos, California, United States, 95032
Actively Recruiting
5
Orthopaedic Spine Institute
Hinsdale, Illinois, United States, 60521
Actively Recruiting
6
Olympia Neurological Institute
Austin, Texas, United States, 78745
Not Yet Recruiting
7
Spine Physician Institute
Dallas, Texas, United States, 75234
Suspended
8
American Neurospine Institute
Frisco, Texas, United States, 75033
Not Yet Recruiting
9
Huntsman Spine
Salt Lake City, Utah, United States, 84124
Actively Recruiting
Research Team
E
Erik M Summerside, PhD
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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