Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05489822
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2022-07-27
Brief Title:
PMCF Study to Evaluate the VERTICALE Cervical System in Spine Surgery According to Its Intended Use
Sponsor:
Silony Medical GmbH
Organization:
Silony Medical GmbH
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In accordance with the European Medical Device Regulation MDR 2017745EU 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
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
Detailed Description:
In accordance with the European Medical Device Regulation MDR 2017745EU 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
The investigators interest is the continuous improvement of the surgical procedure in the context of degenerative cervical spine diseases Patient satisfaction as well as the avoidance of possible complications are the main focus here In addition CE-certified medical devices must be evaluated for long-term performance and safety in clinical practice in accordance with the Medical Devices Act The VERTICALE Cervical System is a rod-screw system for immobilization immobilization and stabilization of the affected segments in the area between the occiput the cervical spine and the upper thoracic spine up to the 3rd thoracic vertebral body Surgical intervention with the VERTICALE Cervical System is performed from behind posteriorly and usually serves to stiffen the affected areas
The goals of surgical intervention depend on the exact clinical picture and the associated symptoms but usually consist of surgical relief of the affected structures of the nervous apparatus andor spinal cord stabilization of the bony structures to restore andor maintain function and relief of pain
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
The investigators interest is the continuous improvement of the surgical procedure in the context of degenerative cervical spine diseases Patient satisfaction as well as the avoidance of possible complications are the main focus here In addition CE-certified medical devices must be evaluated for long-term performance and safety in clinical practice in accordance with the Medical Devices Act The VERTICALE Cervical System is a rod-screw system for immobilization immobilization and stabilization of the affected segments in the area between the occiput the cervical spine and the upper thoracic spine up to the 3rd thoracic vertebral body Surgical intervention with the VERTICALE Cervical System is performed from behind posteriorly and usually serves to stiffen the affected areas
The goals of surgical intervention depend on the exact clinical picture and the associated symptoms but usually consist of surgical relief of the affected structures of the nervous apparatus andor spinal cord stabilization of the bony structures to restore andor maintain function and relief of pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None