Study population
malignancy, spondylolisthesis, infections, cervical/lumbar, malignant tumors, pseudoarthrosis, spondylosis, osteoporosis
ADVERSE EVENTS, DISC DEGENERATIVE DISEASE, SPONDYLOLISTHESIS, INFECTIONS, JOINT DISEASE, MALIGNANT TUMORS, INFECTIOUS DISEASE, PSEUDOARTHROSIS, OSTEOPOROSIS, SPONDYLOSIS, OSTEOMALACIA
This prospective, multicenter, post-market registry study collecting clinical and radiographic outcomes was conducted to evaluate the safety and efficacy of ViBone in patients 18–80 years of age with spondylosis, spondylolisthesis, degenerative disc disease, or herniated nucleus pulposus. Cervical fusion patients were included if they underwent anterior cervical discectomy and fusion (ACDF) surgery using ViBone at 1–3 contiguous levels between C2 and C7; included lumbar fusion patients underwent lumbar interbody fusion surgery using ViBone at 1 to 3 contiguous levels between L1 and S1. Each site obtained IRB approval prior to the initiation of enrollment, and patients were provided with written informed consent before participating in any study-related activities. Exclusion criteria were: patients on long-term medications known to inhibit fusion or bone metabolism, or immune suppressants 6 months before surgery; treatment with radiotherapy; cervical and lumbar fusion during the same procedure; acute/chronic systemic/localized spinal infections; instability associated with major reconstructive surgery for primary/metastatic malignant tumors of the cervical/lumbar spine; previous pseudoarthrosis at any level of the cervical/lumbar spine; current/recent history of malignancy or infectious disease; inability to provide informed consent; rapid joint disease, bone absorption, osteomalacia, and/or diagnosed osteoporosis (Z score of ≤ − 2.5); any other medical/surgical condition which would preclude the potential benefit of surgery. Safety evaluation included incidence of serious adverse events related to the use of ViBone.