Trials / Enrolling By Invitation
Enrolling By InvitationNCT04770571
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
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- NuVasive · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 fixation fusion surgery. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with traumatic, reconstructive, and/or tumor conditions in the craniocervical, cervical, and/or upper thoracic spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the study, subjects will undergo posterior occipito-cervico-thoracic fixation surgery using one of the NuVasive posterior fixation systems (Vuepoint II OCT or Reline-C) based on the surgeon's standard of care. At least 150 subjects (a minimum of 75 in each implant arm) will be enrolled and will be followed for 24 months after the surgery.
Conditions
- Degenerative Disc Disease
- Craniocervical Injuries
- Cervical Radiculopathy
- Cervical Disc Disease
- Cervical Fusion
- Cervical Spine Disease
- Cervical Myelopathy
- Cervical Instabilities Spine
- Thoracic Injury
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | observational study | observational |
Timeline
- Start date
- 2022-05-10
- Primary completion
- 2026-09-01
- Completion
- 2028-11-01
- First posted
- 2021-02-25
- Last updated
- 2025-12-22
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04770571. Inclusion in this directory is not an endorsement.