Sponsor-initiated, prospective, monocentric, non-interventional clinical observational study to evaluate the VERTICALE® Cervical System in spine surgery use according to the intended purpose.

• Conditions: M50.3; M54; M48; M47; M50; Other cervical disc degeneration; Dorsalgia; Other spondylopathies; Spondylosis; Cervical disc disorders

• Registration Number: DRKS00028627
• Lead Sponsor: Silony Medical GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 43

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 Trauma
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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Neck Disability Index (NDI) preoperatively compared with postoperatively (3 and 12 months FU).

Secondary Outcome Measures

Name	Time	Method
Investigation of safety:<br>Complications/risks incl. classification in relation to implant and manifestation<br>- General risks of surgery: including anesthesia risks, infections, bleeding, nerve injuries<br>- Procedure-related surgical risks: including connection degeneration, fracture, nerve root damage<br>- Potential implant-related risks: including implant fracture, dislocation, migration<br>Clinical Performance Examination:<br>- Postoperative assessment using radiographs and supplemental cross-sectional imaging (CT, MRI) as appropriate<br>Examination of effectiveness/patient satisfaction:<br>Reduction in pain measured with the NRS neck pain (cervical spine) and NRS arm pain).<br>JOA to assess myelopathy