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Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex — COSINE  

Idiopathic Scoliosis Clinical Trial

Official title:
Multicenter Post Market Clinical Follow-Up (PMCF) Study on the Safety and Performance of Ennovate® Complex - A Prospective Study on Scoliosis Patients

Clinical Trial Summary

Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in selected centers (not interventional, multicentric)

Clinical Trial Description

This clinical study is one of the Post-Market Clinical Follow-Up (PMCF) measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Complex system. The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in deformity disorders. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05281757
Study type Observational
Source Aesculap AG
Contact Sarah Mattes
Phone +497461950
Email sarah.mattes@aesculap.de
Status Recruiting
Phase
Start date February 18, 2022
Completion date October 2028
View Details
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