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Observational clinical study of the CE marked titanium cage family tezo

Observational clinical study of the CE marked titanium cage family tezo - tezo 2020-1

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025902
Enrollment
110
Registered
2021-07-20
Start date
2021-05-18
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M40-M54

Interventions

Group 1: Non-interventional study: retrospective survey arm 1, no intervention. No examinations, no visits.

Sponsors

ulrich GmbH & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

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

Exclusion criteria: none

Design outcomes

Primary

MeasureTime frame
The primary endpoint is postoperative improvement in the Core Outcome Measures Index (COMI).

Secondary

MeasureTime frame
- postoperative COMI back - postoperative back pain and leg pain on a numeric pain reporting scale (NPRS) - Fusion status at last routine check-up (lenke classification) - Intra- and postoperative complications (especially implant- and procedure-related complications)

Countries

Germany

Contacts

Public ContactMarcus Richter

St. Josefs Hospital

mrichter@joho.de0611 177-3701

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026