Observational Study of Posterior Cervical Fixation Systems
This study is looking at the safety and performance of posterior fixation systems (Vuepoint II OCT or Reline-C) used in neck and upper back surgery. It aims to understand any potential risks and how well these systems work over time. You might be able to join if you are 18 or older and are having surgery for conditions like degenerative disc disease, injuries, or instability in your neck or upper back that requires posterior fixation. The study will measure complications and how well the bones heal (radiographic success) over 24 months to see if the treatment is successful. The study is currently unclear about its recruitment status.
- Study design
- This is an observational study involving at least 150 participants across multiple centers. It is not randomized or blinded, meaning participants will receive standard care and researchers will observe outcomes.
- What's involved
- You would undergo posterior occipito-cervico-thoracic fixation surgery using one of the study's systems. You would then be followed for 24 months after your surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 24 months after their surgery to assess complications and radiographic success.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Posterior Cervical Fixation Study
At a glance
Conditions
Where it's being run
7 sites across 7 statesStudy leadership
- Kyle Malone, MS · STUDY_DIRECTOR · NuVasive
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Complications of Posterior Fixation System24 months
Rate of complications (i.e., safety) attributable to the use of the associated posterior fixation system.
- Radiographic Success24 months
The proportion of subjects with apparent radiographic success at: 1. Latest timepoint available for patients undergoing surgery to treat advanced stage tumors 2. 24 months postoperative for subjects undergoing surgery to treat instabilities, traumatic spinal fractures, failed previous fusions, or degenerative disease