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NCT05489822 · ClinicalTrials.gov registry record
PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
A clinical trial of Trauma and Degenerative Disc Disease (DDD), sponsored by Silony Medical.
- Recruiting
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT05489822: Recruiting study of Trauma and Degenerative Disc Disease (DDD), sponsored by Silony Medical.
NCT05489822 is a study of Trauma and Degenerative Disc Disease (DDD) that is actively recruiting participants, run by Silony Medical. The registered enrollment target is 20 participants, below the 307-participant average among 56 other Trauma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05489822, a study of Trauma and Degenerative Disc Disease (DDD), is actively recruiting participants, sponsored by Silony Medical.
- RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The primary endpoint for this PMCF (Post-Market Clinical Follow-Up) study will be the PROM (Patient-reported Outcome Measurement) instrument Neck Disability Index (NDI). This questionnaire is scientifically accepted. \[1\] The aim is to show an improvement of the NDI in comparison pre-op to post-op (12 months follow-up (± 1 month)). The reference for the primary endpoint NDI is a 2008 publication by Hovard Vernon, "The Neck Disability Index: State-of-the-Art, 1991-2008." \[1\] This comparative o
Conditions Studied
Interventions
- DEVICE VERTICALE® Cervical System
Study Locations (1)
Illinois
- University of Illinois Hospital and Health Sciences System - UI Health - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-01-13 |
| Est. Completion | 2026-04 |
What NCT05489822 shows while recruiting
NCT05489822 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 307-participant average among 56 other Trauma trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Trauma appearing as the primary indexed condition, and to 1 intervention - of which VERTICALE® Cervical System is the first listed.
NCT05489822 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05489822 about?
NCT05489822 is a clinical study titled "PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.". 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 spin...
What is the current status of trial NCT05489822?
This trial is currently recruiting. The enrollment target is 20 participants. The study started on 2023-01-13. Estimated completion is 2026-04.
What conditions does trial NCT05489822 study?
This clinical trial studies the following conditions: Trauma, Degenerative Disc Disease (DDD), Deformity, Instabilities.
What interventions are being tested in trial NCT05489822?
The interventions under investigation include: VERTICALE® Cervical System (DEVICE).
Who is sponsoring clinical trial NCT05489822?
This trial is sponsored by Silony Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05489822 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05489822's enrollment target sits among peer trials
20 51st of 56 higher than 5 of 56 other Trauma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Trauma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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