PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
Public ClinicalTrials.gov record NCT05489822. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Sponsor-initiated, Prospective, Single-center, Non-interventional Clinical Observational Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety. The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3). Primary Objective: To assess the functional outcome and clinical benefit of the VERTICALE® Cervical System for the patient using the NDI (Neck Disability Index) questionnaire. Primary endpoint hypothesis: The investigators hypothesize that NDI improves by at least 10% or 5 points at 12 months FU (Follow-Up) compared with preoperatively.
Study identification
- NCT ID
- NCT05489822
- Recruitment status
- Terminated
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 4 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 12, 2023
- Primary completion
- Nov 29, 2024
- Completion
- Nov 29, 2024
- Last update posted
- May 10, 2026
2023 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Illinois Hospital and Health Sciences System - UI Health | Chicago | Illinois | 60612 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05489822, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 10, 2026 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05489822 live on ClinicalTrials.gov.