Posterior Cervical Fixation Study
Condition(s) studied
Investigational drug(s) / intervention(s)
observational study: observational
Study 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.
Eligibility
Primary outcome measure(s)
- Complications of Posterior Fixation System — 24 months
Rate of complications (i.e., safety) attributable to the use of the associated posterior fixation system. - Radiographic Success — 24 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
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| UC Irvine Medical Center | Orange | California | |
| Hartford Healthcare Bone & Joint Institute | Hartford | Connecticut | |
| MedStar Health Research Institute | Hyattsville | Maryland | |
| NY Spine Institute | New York | New York | |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| Houston Methodist | Houston | Texas |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04770571 on ClinicalTrials.gov ↗ ← All trials in the USA