Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System

Study Overview
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Brief Summary
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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.

Official Title
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The Fusion Rate With K2M VESUVIUS® Demineralized Fibers Used With K2M EVEREST® Spinal System Compared to Autologous Bone Graft With Posterior Stabilization

Conditions
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Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | All adverse events will be documented including device related, procedure related and additional serious adverse events. | 24 months | 
| Fusion Status on CT at 12 Months | Fusion is categorized as Partial consolidation and Bridging/Fusion. Partial consolidation is defined as consolidation of bone graft material with no complete bridging seen. Bridging/Fusion is defined as clear evidence of solid bridging bone between posterolateral gutters, facet joints and/or transverse processes. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Assessments | X-rays at pre-operative and post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include: Posterior/Transverse process fusion, Right side (by level) Posterior/Transverse process fusion, Left side (by level) Anterior fusion, if TLIF procedure done, by level Overall fusion by level Device Condition Device Subsidence Device Migration | 12m | 
| Radiographic Assessments | X-rays at post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include: Device Condition Device Subsidence Device Migration | 12 Months and 24 Months | 
| Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from 0 up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%. | Baseline (Pre-Op), 24 months | 
| Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | VAS scale ranged from 0 to 100mm with the 100mm accounting for the highest level of pain | Baseline (up to 8 weeks post-operatively) to 24 months | 
| Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months | SF-12v2 ranged between 0 and 100 points. The higher the points the better the self-assessed quality of life. | Baseline (up to 8 weeks post-operatively) to 24 months | 
| Patient Satisfaction | Patient Satisfaction at 12 Mo and 24 Mo | 12 months, 24 months | 
| Length of Surgery Time | The length of the surgical procedure from the initial incision to final closure. | At time of surgery | 
| Length of Anesthesia Time | The length of time the patient is under anesthesia. | At time of surgery | 
| Estimated Blood Loss | The amount of blood loss over the entire length of the surgery | At time of surgery | 
| Length of Hospital Stay | The length of the hospital stay from the date of admission to the date of discharge . | Admission to discharge | 
| Time to Return to Work/School | The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the percentage increase of participants who were able to return to work without any restrictions. | Pre-Op to 24 months | 
| Use of Narcotics Post-surgery | The types and dosages of any narcotics taken by the patient post-surgery will be documented. | Pre-Op to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal stenosis, Spondylolisthesis, Degenerative disc disease, Spinal fusion, Allograft, Interbody fusion