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.
Study Type
OBSERVATIONAL
Enrollment
108
Number of Participants With Adverse Events
All adverse events will be documented including device related, procedure related and additional serious adverse events.
Time frame: 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.
Time frame: 12 months
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
Time frame: 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
Time frame: 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%.
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Time frame: 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
Time frame: 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.
Time frame: Baseline (up to 8 weeks post-operatively) to 24 months
Patient Satisfaction
Patient Satisfaction at 12 Mo and 24 Mo
Time frame: 12 months, 24 months
Length of Surgery Time
The length of the surgical procedure from the initial incision to final closure.
Time frame: At time of surgery
Length of Anesthesia Time
The length of time the patient is under anesthesia.
Time frame: At time of surgery
Estimated Blood Loss
The amount of blood loss over the entire length of the surgery
Time frame: At time of surgery
Length of Hospital Stay
The length of the hospital stay from the date of admission to the date of discharge .
Time frame: 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.
Time frame: 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.
Time frame: Pre-Op to 24 months