The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported outcomes (PROs).This study is being undertaken to identify possible residual risks and to clarify mid-to long-term clinical performance that may affect the benefit/risk ratio of posterior fixation systems.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Complications of Posterior Fixation System — 24 months Rate of complications (i.e., safety) attributable to the use of the associated posterior fixation system.
Radiographic Success — 24 months The proportion of subjects with apparent radiographic success at:
1. Latest timepoint available for patients undergoing surgery to treat advanced stage tumors
2. 24 months postoperative for subjects undergoing surgery to treat instabilities, traumatic spinal fractures, failed previous fusions, or degenerative disease
Trial sites (7)
Facility
City
Region
Status
UC Irvine Medical Center
Orange
California
Hartford Healthcare Bone & Joint Institute
Hartford
Connecticut
MedStar Health Research Institute
Hyattsville
Maryland
NY Spine Institute
New York
New York
University of Pittsburgh Medical Center (UPMC)
Pittsburgh
Pennsylvania
Vanderbilt University Medical Center
Nashville
Tennessee
Houston Methodist
Houston
Texas
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.