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

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Long-term use (\>6 months) of opioids \>120 mg morphine equivalents.
• Known allergy to titanium (Ti)
• A current or recent history (≤1 year prior to screening) of substance abuse that required medical treatment.
• Is pregnant, nursing, or interested in becoming pregnant within the next 3 years from the time of screening.
• Participation as a subject in any other clinical studies involving medical devices or drugs in the last 30 days prior to surgery
• A pending personal litigation relating to spinal injury (worker's compensation is not exclusionary).
• Anticipated or potential relocation greater than 50 miles that may interfere with completion of follow-up examinations.
• A mental illness or belongs to a vulnerable population, as determined by the investigator (e.g., prisoner or developmentally disabled), that would compromise ability to provide informed consent or compliance with follow-up requirements.