M40-M54
Conditions
Interventions
Group 1: non-interventional study: retrospective evaluation arm 1, no intervention
Sponsors
ulrich GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient is at least 18 years old; 2. The patient has undergone surgery with uCentum at least one year and at most five years ago; 3. The patient is capable of understanding the nature, significance, and implications of their decision to participate in the clinical observational study and can act accordingly; 4. A consent form, personally dated and signed by the patient, is available.
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is postoperative improvement in the Core Outcome Measures Index (COMI). It is collected via questionnaires and recorded once retrospectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| - postoperative COMI back - postoperative back pain and leg pain on a numeric pain rating scale (NPRS; numeric pain rating scale) - fusion status at last routine check-up (Lenke classification) - Infra- and postoperative complications (especially implant- and procedure-related complications) | — |
Countries
Germany
Contacts
Public ContactMarcus Richter
St. Josefs Hospital
Outcome results
None listed