Status:
ENROLLING_BY_INVITATION
Posterior Cervical Fixation Study
Lead Sponsor:
NuVasive
Conditions:
Degenerative Disc Disease
Craniocervical Injuries
Eligibility:
All Genders
18+ years
Brief 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, ...
Detailed Description
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 fix...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04770571
Start Date
May 10 2022
End Date
November 1 2028
Last Update
December 22 2025
Active Locations (7)
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1
UC Irvine Medical Center
Orange, California, United States, 92868
2
Hartford Healthcare Bone & Joint Institute
Hartford, Connecticut, United States, 06106
3
MedStar Health Research Institute
Hyattsville, Maryland, United States, 20782
4
NY Spine Institute
New York, New York, United States, 10003