NuVasive® ACP System Study (NCT05066711) | Clinical Trial Compass
By InvitationNot Applicable
NuVasive® ACP System Study
United States75 participantsStarted 2022-05-22
Plain-language summary
The primary objective of this study is to evaluate the safety and performance of anterior cervical spine surgery using the NuVasive anterior cervical plate (ACP) System as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients who are ≥18 years of age at the time of consent
✓. Have planned anterior cervical (C2 to C7) spine surgery using the NuVasive ACP System in conjunction with a NuVasive interbody implant or vertebral body replacement device (VBR), or a structural bone allograft spacer, for treatment of any of the following conditions:
✓. 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 involving the cervical spine
✓. cervical spinal deformity (kyphosis, lordosis, or scoliosis)
. Patient has known sensitivity to materials implanted
✕. Systemic or local infection (latent or active) or signs of local inflammation
✕. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment