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PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.

NCT05489822 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2026-05-11

No results posted yet for this 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.

Conditions

  • Degenerative Disc Disease (DDD)
  • Instabilities
  • Trauma
  • Deformity

Interventions

DEVICE

VERTICALE® Cervical System

All measures and devices mentioned in the study protocol correspond to routine clinical practice with the exception of the following questionnaires: NDI (Neck Disability Index) NRS (Numerical Rating Scale) neck pain (cervical spine) and NRS arm pain mJOA (modified Japanese Orthopaedic Association) Score

Sponsors & Collaborators

  • Silony Medical GmbH

    lead INDUSTRY

Principal Investigators

  • Ankit I. Mehta, MD · University of Illinois Hospital and Health Sciences System - UI Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-13
Primary Completion
2024-11-30
Completion
2024-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05489822 on ClinicalTrials.gov