M50.3 M54 M48 M47 M50 M54
Conditions
Interventions
Group 1: Patients with damage or diseases of the musculoskeletal system that require surgery.
musculoskeletal system:
- Degenerative disc diseases (DDD)
- Instabilities
- Trauma
- Deformities
Patients
Sponsors
Silony Medical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Neck Disability Index (NDI) preoperatively compared with postoperatively (3 and 12 months FU). | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigation of safety: Complications/risks incl. classification in relation to implant and manifestation - General risks of surgery: including anesthesia risks, infections, bleeding, nerve injuries - Procedure-related surgical risks: including connection degeneration, fracture, nerve root damage - Potential implant-related risks: including implant fracture, dislocation, migration Clinical Performance Examination: - Postoperative assessment using radiographs and supplemental cross-sectional imaging (CT, MRI) as appropriate Examination of effectiveness/patient satisfaction: Reduction in pain measured with the NRS neck pain (cervical spine) and NRS arm pain). JOA to assess myelopathy | — |
Countries
Germany
Contacts
Public ContactJana Wilke
Klinik für Spinale Chirurgie, Schön Klinik Holding SE
Outcome results
None listed