Observational clinical study of the CE-markediliosacral fixation system uBase

• Conditions: M40-M54; Dorsopathies

• Registration Number: DRKS00024757
• Lead Sponsor: ulrich GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-12
• Study Completion: 2022-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

1. patient is at least 18 years old;
2. patient has undergone surgery with uBase in the period between 08/25/2015 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
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).

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<br>- Infra- and postoperative complications (especially implant- and procedure-related<br>complications)