Clinical observational study of the CE-marked uCentum

• Conditions: Dorsopathies; M40-M54

• Registration Number: DRKS00024661
• Lead Sponsor: ulrich GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-03
• Study Completion: 2022-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

1) Patient is at least 18 years old;
2) Patient has undergone surgery with uCentum in the period between 06/01/2015 and 05/31/2019;
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 will accordingly;
4) An informed consent form, dated and signed by the patient's own hand, 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).<br>It is collected via questionnaires and recorded once retrospectively.

Secondary Outcome Measures

Name	Time	Method
- postoperative COMI back<br>- postoperative back pain and leg pain on a numeric pain rating scale (NPRS;<br>numeric pain rating scale)<br>- fusion status at last routine check-up (Lenke classification)<br>- Infra- and postoperative complications (especially implant- and procedure-related complications)