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

Terminated

Conditions: Spondylolisthesis
Spinal Stenosis
Degenerative Disc Disease

Registration Number: NCT02064855

Lead Sponsor: K2M, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 108

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	24 months	All adverse events will be documented including device related, procedure related and additional serious adverse events.
Fusion Status on CT at 12 Months	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.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	12 months, 24 months	Patient Satisfaction at 12 Mo and 24 Mo
Length of Surgery Time	At time of surgery	The length of the surgical procedure from the initial incision to final closure.
Length of Anesthesia Time	At time of surgery	The length of time the patient is under anesthesia.
Radiographic Assessments	12 Months and 24 Months	X-rays at post operative include: AP\& Lateral; Flex/Ext \& Oblique X-rays. Radiographic assessments being performed include: Device Condition Device Subsidence Device Migration
Estimated Blood Loss	At time of surgery	The amount of blood loss over the entire length of the surgery
Length of Hospital Stay	Admission to discharge	The length of the hospital stay from the date of admission to the date of discharge .
Use of Narcotics Post-surgery	Pre-Op to 24 months	The types and dosages of any narcotics taken by the patient post-surgery will be documented.
Time to Return to Work/School	Pre-Op to 24 months	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.
Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months	Baseline (up to 8 weeks post-operatively) to 24 months	SF-12v2 ranged between 0 and 100 points. The higher the points the better the self-assessed quality of life.
Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI)	Baseline (Pre-Op), 24 months	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%.
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months	Baseline (up to 8 weeks post-operatively) to 24 months	VAS scale ranged from 0 to 100mm with the 100mm accounting for the highest level of pain