🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT04770571
Enrolling by invitation Observational

Posterior Cervical Fixation Study

NCT04770571 · tracked via the Priya Life Science USA tracker
Sponsor
NuVasive
Phase
Observational
Started
2022-05-10
Last updated
2025-12-22

Condition(s) studied

Degenerative Disc DiseaseCraniocervical InjuriesCervical RadiculopathyCervical Disc DiseaseCervical FusionCervical Spine DiseaseCervical MyelopathyCervical Instabilities SpineThoracic Injury

Investigational drug(s) / intervention(s)

observational study

observational study: observational

Study summary

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)

Trial sites (7)

FacilityCityRegionStatus
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.

View NCT04770571 on ClinicalTrials.gov ↗ ← All trials in the USA