DRKS00028627Not yet recruitingNot Applicable
Sponsor-initiated, prospective, monocentric, non-interventional clinical observational study to evaluate the VERTICALE® Cervical System in spine surgery use according to the intended purpose. - PMCF Study VERTICALE Cervical
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Silony Medical GmbH
- Enrollment
- 43
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •Ability to read, understand and speak the local language fluently to ensure understanding of
- •- Informed consent and protocol specific examinations
- •- The surgical indication must be one or a combination of the following
- •o Degenerative disc disease (DDD)
- •o Instabilities
- •o Deformities
- •- Monosegmental, bisegmental, and multisegmental treatment (occipital-T3).
- •- Age: = 18 years
- •- Subject must provide written informed consent prior to all clinical trial related procedures.
Exclusion Criteria
- •Absolute contraindications
- •Under certain circumstances, implantation is prohibited or associated with significant risks despite a given indication. These include in particular:
- •- Expected or documented allergy or intolerance to materials (e.g., titanium or cobalt-chromium).
- •- Any case in which the selected implants would be too large or too small to achieve a successful result
- •- Any patient in whom the use of the implant would conflict with anatomical structures
- •- Lack of bony structures that would prevent good anchorage of the implant (e.g., fracture, tumor, or osteoporosis)
- •Relative contraindications
- •- Overweight of the patient
- •- Fever or leukocytosis
- •- Systemic diseases and metabolic disorders
- •- Unbalanced diet, drug abuse, nicotine, alcohol, drug consumption
- •- Physical activities associated with strong shocks, where the implant is subjected to blows and/or excessive stresses (e.g., heavy physical work, competitive sports, marathons, alpine skiing, jumping and team sports).
- •- Patient who is mentally incapable of understanding and following the physician's instructions
- •- Osteoporosis or osteomalacia
- •- Surgeries on pregnant women should be avoided if possible. If they are nevertheless performed, they require special care or procedure. Any concomitant diseases that may jeopardize the function and success of the implant.
- •- Any patient who has insufficient tissue coverage
- •- Severe muscular, nervous or vascular diseases that endanger the affected extremities
- •- Acute or chronic infections, local or systemic
Investigators
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