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

Launched by SILONY MEDICAL GMBH · Aug 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medical device called the VERTICALE® Cervical System, which is used in spine surgery to help stabilize and support certain areas of the neck and upper spine. The goal of the trial is to see how well this device helps patients with conditions like degenerative disc disease, spinal instability, trauma, or deformities. Researchers will measure the improvement in neck function and quality of life using a simple questionnaire called the Neck Disability Index (NDI). They hope to find that patients experience at least a 10% improvement in their condition after 12 months of using the device.

To participate in this study, you must be at least 18 years old and able to read and understand the local language. You should have a medical condition that qualifies for this surgery, such as degenerative disc disease or spinal instability. However, certain factors may exclude you, like allergies to the materials used in the device, active infections, or specific anatomical issues. If you join the trial, you’ll provide written consent and receive careful monitoring to assess how the VERTICALE® Cervical System is helping your condition over time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• 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.