The purpose of this post-market study is to collect data on ViviGen and how its use affects fusion rates in the cervical spine when used as additional grafting material to fill the cervical spacer. The patient population of interest is patients who have already elected to undergo a 2-3 level ACDF surgical procedure using ViviGen, per standard of care.
Study Type
OBSERVATIONAL
Enrollment
100
ViviGen Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone. ViviGen is a Human Cells, Tissues, and Cellular and Tissue-based Product (HCT/P) as defined by the U.S. Food and Drug Administration in 21 CFR 127 1.3(d).
Fusion
An independent radiologist will review films to determine fusion
Time frame: 12 Months
VAS (Visual Analog Scale)
Patient neck and arm pain reported on a VAS
Time frame: 12 Months
NDI (Neck Disability Index)
Functional success based on results from the NDI
Time frame: 12 Months
SF-12
Quality of life using SF-12 questionnaire
Time frame: 12 Months
OR (Operating Room) Time
Length of time to complete the two or three level ACDF (Anterior Cervical Discectomy and Fusion) using ViviGen
Time frame: 0 Days
Length of Hospital Stay
Length of time the patient remains in the hospital before being discharged after their two or three level ACDF using ViviGen
Time frame: 12 Months
Return to Work
How many patients return to work after having their two or three level ACDF using ViviGen
Time frame: 12 Months
Adverse Events
Rate of adverse events (AEs)
Time frame: 12 Months
Time to Fusion
Time to fusion as assessed by plain films
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 Months