Posterior Cervical Fixation Study

Enrolling by invitation

Conditions studied: Degenerative Disc Disease, Craniocervical Injuries, Cervical Radiculopathy, Cervical Disc Disease, Cervical Fusion, Cervical Spine Disease, Cervical Myelopathy, Cervical Instabilities Spine, Thoracic Injury

In brief

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.

Key facts

Study ID

NCT04770571

Run by

NuVasive

People needed

150

Starts

2022-05-10

Expected to finish

2028-11-01

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are ≥18 years of age at the time of consent
• 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:
• traumatic spinal fractures and/or traumatic dislocations
• instability or deformity
• failed previous fusions (e.g., pseudoarthrosis)
• tumors involving the cervical spine
• 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
• Using one of the following posterior occipito-cervico-thoracic fixation systems (NuVasive, Inc, San Diego, CA):
• Vuepoint II OCT
• Reline-C
• Able to undergo surgery based on physical exam, medical history, and surgeon judgment
• Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study

You may not qualify if…

• Patient is involved in active litigation relating to the spine (workers' compensation 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 condition that 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

Where it is running

• UC Irvine Medical Center — Orange, California, United States
• Hartford Healthcare Bone & Joint Institute — Hartford, Connecticut, United States
• MedStar Health Research Institute — Hyattsville, Maryland, United States
• NY Spine Institute — New York, New York, United States
• University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Houston Methodist — Houston, Texas, United States

Full record on ClinicalTrials.gov

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