Observational clinical study of the CEmarked rod-screw system neon 3

• Conditions: M40-M54; Dorsopathies

• Registration Number: DRKS00025932
• Lead Sponsor: ulrich GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-22
• Study Completion: 2022-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. patient is at least 18 years old;
2. patient has undergone surgery with neon3 at least one and no more than five years ago;
3. patient is capable of recognizing the nature, significance and scope of his decision to participate in the clinical observational study and to orient 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 neck<br>- postoperative neck pain and arm pain on a numeric pain reporting scale (NPRS)<br>- Fusion status at last routine checkup (lenke classification)<br>- Intra- and postoperative implant- and procedure-related complications