The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. Specifically, the study aims to collect the data for ACDF model utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Age\>18 years
✓. Scheduled 1 or 2-level ACDF spine surgery
✓. The capacity to provide informed consent.
✓. Subject has one or more of the following diagnoses:
✓. Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
✓. Trauma (including fractures)
✓. Tumors
✓. Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Exclusion criteria
✕. Patients with current or recent history of malignancy or infectious disease.
✕. The inability to provide informed consent.
✕. Subject has marked local inflammation
✕. Subject has any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.
✕. Subject has a bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the devices.
. Subject has bone abnormalities preventing safe screw fixation.
✕. Subject has any open wounds.
✕. Subject has rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis. Osteoporosis or osteopenia are relative contraindications, since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.