Phase
Condition
Spondylolisthesis
Spinal Cord Disorders
Radiculopathy
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ACPSystem in conjunction with a NuVasive interbody implant or vertebral bodyreplacement device (VBR), or a structural bone allograft spacer, for treatment ofany of the following conditions:
degenerative disc disease, as defined by neck pain of discogenic origin withdegeneration 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)
failed previous cervical fusion(s) (e.g., pseudoarthrosis)
cervical spondylolisthesis
cervical spinal stenosis
Able to undergo surgery based on physical exam, medical history, and surgeonjudgment
Understands the conditions of enrollment and is willing to sign an informed consentform to participate in the study
Exclusion
Exclusion Criteria:
Procedures performed with interbody implants with integrated vertebral body screw(s)
Patient is involved in active litigation relating to the spine (worker'scompensation claim is allowed if it is not contested)
Use of bone growth stimulators postoperatively
Active smoking within 6 weeks of surgery
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 conditionthat would prohibit beneficial surgical outcome based on surgeon judgment
Pregnant, or plans to become pregnant
Patient is a prisoner
Patient is participating in another clinical study that would confound study data
Study Design
Study Description
Connect with a study center
Duly Health and Care
Naperville, Illinois 60540
United StatesSite Not Available
Columbia Orthopedic Group Research
Columbia, Missouri 65201
United StatesSite Not Available
Atlantic Brain and Spine
Wilmington, North Carolina 28401
United StatesSite Not Available
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