Clinical trial · Observational
Posterior Cervical Fixation Study
A Prospective, Multicenter Study Evaluating the Safety and Performance of Posterior Fixation in Trauma, Reconstructive, and Tumor Surgery of the Occipito-cervico-thoracic Spine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Disc Disease | — | UNRESOLVED | — |
| Cervical Fusion | — | UNRESOLVED | — |
| Cervical Instabilities Spine | — | UNRESOLVED | — |
| Cervical Myelopathy | — | UNRESOLVED | — |
| Cervical Radiculopathy | — | UNRESOLVED | — |
| Cervical Spine Disease | — | UNRESOLVED | — |
| Craniocervical Injuries | — | UNRESOLVED | — |
| Degenerative Disc Disease | — | UNRESOLVED | — |
| Thoracic Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| observational study | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Vuepoint II OCT
- interventionNames
- Device: observational study
- label
- Reline-C
- interventionNames
- Device: observational study
Primary outcomes (2)
- measure
- Complications of Posterior Fixation System
- timeFrame
- 24 months
- description
- Rate of complications (i.e., safety) attributable to the use of the associated posterior fixation system.
- measure
- Radiographic Success
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available