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Clinical Trial

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

NCT: NCT05489822 · TERMINATED

NCT IDNCT05489822
StatusTERMINATED
Start Date2023-01-13
Completion2024-11-30

Brief 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.

Frequently Asked Questions

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

PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. is a clinical trial registered under NCT05489822. Current status: TERMINATED.

What is the status of NCT05489822?

The current status of NCT05489822 (PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.) is: TERMINATED.

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

PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. started on 2023-01-13.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.