Posterior Cervical Fixation Study

Launched by NUVASIVE · Feb 22, 2021

Keywords

ClinConnect Summary

This is a prospective, multicenter observational study looking at the safety and performance of two posterior spine fixation systems (Vuepoint II OCT and Reline-C) used in surgeries that stabilize the upper spine from the back (occipito-cervico-thoracic region). About 150 adults who are having this type of surgery for trauma, instability, tumors, or degenerative disease will be followed for 24 months after their operation. The study will track how often there are hardware-related complications and what X-ray images show about spine stability and fusion, along with patient-reported outcomes such as neck/arm pain, neck-related disability, and overall physical and mental health.

To be eligible, adults 18 and older must be planned for craniocervical, cervical (C1–C7), or upper thoracic (T1–T3) posterior fixation surgery using one of the two devices, for conditions like traumatic fractures or dislocations, instability or deformity, failed prior fusions, tumors, or degenerative disease with nerve symptoms. Exclusions include active spine-related lawsuits, recent smoking, infection, poor bone quality, pregnancy, or participation in another conflicting study. Participation involves standard surgery with one of the devices and follow-up visits for 24 months. Results are not yet available; the study is currently enrolling by invitation and is planned to conclude around 2028.

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