Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System
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The purpose of this study is to evaluate fusion status and patient outcomes observed from use of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the literature reported outcomes of spinal fusion using autograft with posterior stabilization.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects will be identified from the surgeon's practice.
Diagnosis of non-cervical spinal stenosis; spondylolisthesis (grade 1 or 2); and/or degenerative disc disease (DDD) with one or two contiguous levels requiring surgical intervention between L1-S1. Qualified patients will be confirmed for inclusion by patient history and radiographic studies
Willing and able to comply with the requirements of the protocol including follow-up requirements
Willing and able to sign a study specific informed consent
Skeletally mature and I 18 years old at time of enrollment
Previous spine surgery at the index level
Previous posterior spine surgery (e.g., posterior decompression) that destabilizes the lumbar spine
Active systemic infection or infection at the operative site
Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
Metabolic bone disease such as osteoporosis and osteopenia that contradicts spinal surgery
History of an osteoporotic fracture
History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
Known allergy to titanium or cobalt chrome
Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C, or fibromyalgia
Insulin-dependent type 1 or type 2 diabetes
Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
Pregnant, or intends to become pregnant, during the course of the study
Severe obesity (Body Mass Index > 40)
Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain, or quality of life.
Involved in current or pending spinal litigation where permanent disability benefits are being sought
Incarcerated at the time of study enrollment
Current participation in an investigational study that may impact study outcomes