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Clinical observational study of the CE-marked PEEK cage family pezo™

Clinical observational study of the CE-marked PEEK cage family pezo™ - pezo 2020-1

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025930
Enrollment
110
Registered
2021-07-21
Start date
2022-05-18
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

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 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

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