Posterior Cervical Fixation Study

Launched by NUVASIVE · Feb 22, 2021

Keywords

ClinConnect Summary

This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select occipito-cervico-thoracic posterior fixation systems in patients who undergo posterior fixation fusion surgery. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with traumatic, reconstructive, and/or tumor conditions in the craniocervical, cervical, and/or upper thoracic spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who are ≥18 years of age at the time of consent
• 2. Have planned craniocervical, cervical (C1 to C7), and/or upper thoracic (T1-T3) spine surgery using posterior fixation planned for treatment of any of the following conditions:
• • 1. traumatic spinal fractures and/or traumatic dislocations
• • 2. instability or deformity
• • 3. failed previous fusions (e.g., pseudoarthrosis)
• • 4. tumors involving the cervical spine
• • 5. degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability
• 3. Using one of the following posterior occipito-cervico-thoracic fixation systems (NuVasive, Inc, San Diego, CA):
• • 1. Vuepoint II OCT
• • 2. Reline-C
• • 4. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
• • 5. Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study
• Exclusion Criteria:
• • 1. Patient is involved in active litigation relating to the spine (workers' compensation claim is allowed if it is not contested)
• • 2. Use of bone growth stimulators postoperatively
• • 3. Active smoking within 6 weeks of surgery
• • 4. Patient has known sensitivity to materials implanted
• • 5. Systemic or local infection (latent or active) or signs of local inflammation
• • 6. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
• • 7. Pregnant, or plans to become pregnant
• • 8. Patient is a prisoner
• • 9. Patient is participating in another clinical study that would confound study data