M40-M54
Conditions
Interventions
Group 1: patient with cosmicMIA
Sponsors
ulrich GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -Patient is at least 18 years old -Patient is scheduled for surgical dorsal semi-rigid stabilisation and fixation of the adult human thoracic, lumbar and sacral (S1) WS for degenerative spinal disease using cosmicMIA. -The patient is able to recognise the nature, significance and scope of his or her decision to participate in the clinical observational study and to direct his or her will accordingly. -A declaration of consent, dated and signed by the patient himself/herself, is available -Compliance with the IFU of cosmicMIA
Exclusion criteria
Exclusion criteria: -The patient requires instrumentation over more than 3 segments. -Non-compliance with IFU of for cosmicMIA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| revision surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Peri- and postoperative complications Evidence of performance / clinical benefit by means of the following parameters: - Determination of postoperative activity level (using ODI questionnaires). - Change in pain (using VAS scale) | — |
Countries
Germany
Contacts
Public ContactClaudia Genée
GKM Gesellschaft für Therapieforschung mbH
Outcome results
None listed