The purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to published data for autograft in NDI (Neck Disability Index) improvement and radiographic success of fusion.
This is a prospective single-arm multi-center study of Cellentra Viable Cell Bone Matrix (VCBM) and the MaxAn® Anterior Cervical Plate System when used in anterior cervical discectomy and fusion procedures. This study will enroll up to eighty (80) subjects across up to eight (8) clinical sites. Subjects will be recruited from a pool of patients presenting to investigators for an anterior cervical discectomy and fusion procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
Barrow Neurological Associates
Phoenix, Arizona, United States
Fort Wayne Ortho
Fort Wayne, Indiana, United States
Orthopaedic Institute of Western KY
Paducah, Kentucky, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Change in NDI From Baseline
Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each of the 10 items is scored from 0 - 5, with a maximum score of 50. The obtained score is multiplied by 2 to produce a percentage score. A higher score indicates more patient-rated disability (0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation). The minimal clinically important difference or change (MCID / MCIC) is described as the smallest difference or change that patients perceive as beneficial. In patients with cervical radiculopathy the MCID is 7 points of change ( 14%). In order to demonstrate improvement in status, the NDI would need to be reduced by at least 14%.
Time frame: 12 months after device implantation
Number of Participants With Radiographic Success at 24 Months
Radiographic fusion was assessed at each operated level using the Bridwell fusion grading system: * Grade I (definite) - Fused with remodeling and trabeculae * Grade II (probable) - Graft intact, not fully remodeled and incorporated through, no lucencies * Grade III (probably not) - Graft intact, but definite lucency at the top or bottom of the graft * Grade IV (no) - Definitely not fused, with resorption of bone graft or collapse. Radiographic success was defined as grade 1 or 2 fusion at every operated level at 24 months
Time frame: 24 Months
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The Rothman Institute
Philadelphia, Pennsylvania, United States
Spine Team Texas
Southlake, Texas, United States