M50.1 M50.0
Conditions
Interventions
Group 1: Patients will be examined pre- and postoperatively after implantation of SIGNUS Rotaio cervical disc prosthesis as well as after 3, 12 and 24 months. The status will be documented by completi
Sponsors
SIGNUS Medizintechnik GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Intractable mono- or bisegmental radiculopathy due to a degenerative cervical disc disease or intractable myelopathy
Exclusion criteria
Exclusion criteria: Kyphosis in the index segment, instability in the index segment, severe osteochondrosis in the index segment, marked degenerative changes in the facet joints, previous surgery in the cervical spine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Success rate after 24 months: 1. Improvement of the NDI for more than 15% 2. Preservation/Improvement of the neurological Status 3. No re-operation, revision or removal of the implant 4. No complications associated with the implant | — |
Secondary
| Measure | Time frame |
|---|---|
| Determining the quality of life, mobility and freedom from pain by SF-36, NDI, WL-26 and VAS at 12 and 24 months Index of patient satisfaction, analgesic consumption Radiographic mobility after 12 and 24 months | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactIsabell Hock
SIGNUS Medizintechnik GmbH
Outcome results
None listed