PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
NCT: NCT05489822 · TERMINATED
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.