M51 M43.16
Conditions
Interventions
Group 1: Pre-op:
- ODI
- VAS back pain
- VAS Leg pain
- EQ5D
- Neurological status
- X-ray (local segmental lumbar lordosis, total lordosis)
Intra-OP
- Recording of possible complications
- Surgery d
Sponsors
Silony Medical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The ability to read, understand and speak the local language fluently Signed consent form The surgical indication must be one or a combination of the following. o Degenerative disc disease o Deformities o Segmental dysfunction of the lumbar spine or thoracolumbar spine, if applicable o Spondylolisthesis o Segmental instability o Stenoses 1-2 level OPs (L1-S1) Age: 18-75 years
Exclusion criteria
Exclusion criteria: segmental supply of 3 or more levels Contraindications Absolute contraindications - Expected or documented allergy or intolerance to the materials (e.g. titanium). - 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 the anatomical structures. - Missing bony structures that make good anchorage of the implant impossible (e.g. fractures, tumors, osteoporosis or infections). Relative contraindications - Overweight of the patient - deformities - Fever or leukocytosis - Systemic diseases and metabolic disorders - Unbalanced diet, drug abuse, nicotine, alcohol, drug consumption - Physical activities involving strong shocks, where the implant is exposed to blows and/or excessive stress (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. - Operations on pregnant women are to be avoided if possible or require special Care or procedure. This is at the discretion of the surgeon. - Any condition that might preclude the potential benefit of spinal implantation should be clarified by the applying physician. These could be: tumors, local fractures in the area of the surgical site, unexplained increase in erythrocyte sedimentation rate due to other diseases, increase in leukocytes or a significant shift in the differential blood count or other parameters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ODI change at 4 and 12 months post-op compared to pre-op | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and performance: Based on complications intra-OP and post-OP. Assessment segmental fusion, lordosis. Patient satisfaction: Based on VAS back pain and VAS leg pain, and EQ-5D. | — |
Countries
Germany
Contacts
Public ContactUlf Liljenqvist
St. Franziskus-Hospital Münster, Wirbelsäulenchirurgie
Outcome results
None listed