Observational clinical study of the CE-marked semi-rigid rod screw system cosmicMIA™.

Recruiting

• Conditions: M40-M54; Dorsopathies

• Registration Number: DRKS00026692
• Lead Sponsor: ulrich GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

Patient is at least 18 years old
-Patient is scheduled for surgical dorsal semi-rigid stabilisation and fixation of the adult human thoracic, lumbar and sacral (S1) WS for degenerative spinal disease using cosmicMIA.
-The patient is able to recognise 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.
-A declaration of consent, dated and signed by the patient himself/herself, is available
-Compliance with the IFU of cosmicMIA

Exclusion Criteria

-The patient requires instrumentation over more than 3 segments.
-Non-compliance with IFU of for cosmicMIA

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
revision surgery

Secondary Outcome Measures

Name	Time	Method
Peri- and postoperative complications<br>Evidence of performance / clinical benefit by means of the following parameters:<br>- Determination of postoperative activity level (using ODI questionnaires). <br>- Change in pain (using VAS scale)