Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
This study is a prospective, multi-center study to evaluate the clinical and radiographic outcomes of ViBone in patients undergoing ACDF or lumbar interbody fusion. Data will be gathered for subjects undergoing ACDF surgery and subjects undergoing lumbar fusion surgery using ViBone. Total enrollment is expected to be approximately 100 subjects. The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using ViBone. Subjects will be followed for 12 months following surgery.
Study Type
OBSERVATIONAL
Enrollment
118
Viable Bone Allograft
Spine Institute of San Diego
San Diego, California, United States
Connecticut Neck & Back Specialists, LLC
Danbury, Connecticut, United States
Anne Arundel Medical Group
Annapolis, Maryland, United States
Orthopedic Specialists of Austin
Austin, Texas, United States
Fusion Rates Per Level Using the Bridwell Interbody Grading Scale
Successful fusion rates for ViBone as defined by Grade I or II level of fusion on the Bridwell Interbody Grading Scale (below). The percentages below show at 12 months the amount of fusion per level for cervical and lumbar fusion procedures utilizing ViBone. Grade I: Fused with remodeling and trabeculae present. Grade II: Graft intact, not fully remodeled and incorporated, but no lucency present. Grade III: Graft intact, potential lucency present at top and bottom of graft. Grade IV: Fusion absent with collapse/resorption of graft.
Time frame: 12 months
Percent Change From Baseline in Oswestry Disability Index (ODI) at 12 Months
Oswestry Disability Index (ODI) improvement relative to baseline for lumbar spine fusion (0-100) 0 is no disability and 100 is bed-bound.
Time frame: Baseline and 12 months
Percent Change From Baseline in Neck Disability Index (NDI) at 12 Months
Neck Disability Index (NDI) improvement relative to baseline for cervical spine fusion Scale of 0 - 100, where 0 is no problems at all and 100 is severely affected.
Time frame: Baseline and 12 months
Percent Change From Baseline in Visual Analog Scale (VAS) at 12 Months
Visual Analog Scale (VAS) for pain improvement relative to baseline (Pain scale from 0-10, with 0 being No Pain and 10 being Worst Pain)
Time frame: Baseline and 12 months
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