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.
Silony Medical GmbH
20 participants
Jan 13, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 Criteria8
- 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.
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05489822