Clinical observational study characterized PEEK cage pezo™
- Conditions
- M40-M54Dorsopathies
- Registration Number
- DRKS00025930
- Lead Sponsor
- ulrich GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria
1. patient is at least 18 years old;
2. patient has undergone surgery with pezo at least one and no more than five years ago;
3. patient is capable of recognizing 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;
4. an informed consent form, dated and signed by the patient himself, is available.
Exclusion Criteria
none
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is postoperative improvement in the Core Outcome Measures Index (COMI).
- Secondary Outcome Measures
Name Time Method - postoperative COMI back<br>- postoperative back pain and leg pain on a numeric pain reporting scale (NPRS)<br>- Fusion status at last routine check-up (lenke classification)<br>- Intra- and postoperative complications (especially implant- and procedure-related complications)<br>