Last updated: April 17, 2024
Sponsor: Silony Medical GmbH
Overall Status: Active - Recruiting
Phase
N/A
Condition
Hyponatremia
Treatment
VERTICALE® Cervical System
Clinical Study ID
NCT05489822
TDII_2014-003_2.1_103
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Ability to read, understand and speak the local language fluently to ensure understandingof 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
Exclusion Criteria: Relative and absolute contraindications according to IFU (Instruction for Use): Under certain circumstances, implantation is prohibited or associated with substantialrisks, 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 orcobalt chromium).
- Active systemic infection or an infection localized to the site of the proposedimplantation
- Any case in which the chosen implants would be too large or too small to achieve asuccessful 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'soccupation or activity level or mental capacity may be relative contraindications tothis 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 athigher risk for implant failure.
Study Design
Total Participants: 20
Treatment Group(s): 1
Primary Treatment: VERTICALE® Cervical System
Phase:
Study Start date:
January 13, 2023
Estimated Completion Date:
April 30, 2026
Study Description
Connect with a study center
University of Illinois Hospital and Health Sciences System - UI Health
Chicago, Illinois 60612
United StatesActive - Recruiting
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