NCT05489822

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

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
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Silony Medical GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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). 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 and/or spinal cord, stabilization of the bony structures to restore and/or maintain function, and relief of pain.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-13
• Primary completion: 2026-01-01
• Completion: 2026-04-01
• First posted: 2022-08-05
• Last updated: 2024-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study