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

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

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)

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.

Inclusion Criteria:

• Informed consent in the documentation of clinical and radiological results of patients who are minimum 18 years old
• Informed consent in the documentation of clinical and radiological results of patients AND legal representative (parent) for patients who are younger than 18
• Patient's indication according to IFU
• Patient is not pregnant

Exclusion Criteria:

• Patient's clear unability or unwillingness to participate in follow-up examinations