Observational clinical study of the CEmarked titanium cage family tezo

• Conditions: M40-M54; Dorsopathies

• Registration Number: DRKS00025902
• Lead Sponsor: ulrich GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-20
• Study Completion: 2022-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

1. patient is at least 18 years old;
2. patient has undergone surgery with tezo in the period of the last 5 years prior to admission;
3. patient is capable of recognizing the nature, significance, and scope of his or her decision to participate in the clinical
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)