M50.1 M50.2
Conditions
Interventions
Group 1: Patients with a medical indication for the JASPIS ST fusion cage are surgically treated with the implant. They are examined pre- and postoperatively as part of the clinical routine. As part o
Sponsors
SIGNUS Medizintechnik GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Medical indication for surgical treatment of the cervical spine using JASPIS ST, Presence of a declaration of consent, Patients who are at least 18 years old
Exclusion criteria
Exclusion criteria: Age < 18 years, Participants unable to give consent, e.g. due to cognitive impairment, Pregnant and breastfeeding women, Patients for whom consent is not available.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional result Postoperative pain relief Patient satisfaction Quality of life Survey using: Odom's criterion, mJOA, NDI, EQ-5D-5L, PI, analgesic use Survey at all time points of preoperative and postoperative follow-up (except Odom's criterion and PI - postoperative only). | — |
Secondary
| Measure | Time frame |
|---|---|
| Fusion rate (by imaging studies) Sintering (by imaging studies) Safety and implant-associated complications by safety CRF. | — |
Countries
Germany
Contacts
Public ContactIsabell Kern
SIGNUS Medizintechnik GmbH
Outcome results
None listed