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

Stopped early

Conditions studied: Degenerative Disc Disease (DDD), Instabilities, Trauma, Deformity

In brief

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.

Key facts

Study ID

NCT05489822

Run by

Silony Medical GmbH

People needed

4

Starts

2023-01-13

Expected to finish

2024-11-30

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to read, understand and speak the local language fluently to ensure understanding of Informed consent and protocol specific investigations
• The surgical indication must be one or a combination of the following
• Degenerative disc disease (DDD)
• Instabilities
• Trauma
• Deformities
• Mono-, bi- and multisegmental restoration (occipital T3)
• Age: ≥ 18 years
• The subject must give written informed consent before inclusion into the PMCF study.

You may not qualify if…

• Relative and absolute contraindications according to IFU (Instruction for Use):
• Under certain circumstances, implantation is prohibited or associated with substantial risks, even though there may be an indication for it.
• These include in particular:
• Anticipated or documented allergy or intolerance to the materials (e.g., titanium or cobalt chromium).
• Active systemic infection or an infection localized to the site of the proposed implantation
• Any case in which the chosen implants would be too large or too small to achieve a successful result.
• Any patient for whom the use of the implant would conflict with anatomical structures.
• Missing bony structures, which would render solid anchoring of the implant impossible (e.g., in the case of fractures, tumors, or osteoporosis). In addition, the patient's occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure.

Where it is running

• University of Illinois Hospital and Health Sciences System - UI Health — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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