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
Aesculap AG
200 participants
Feb 18, 2022
OBSERVATIONAL
Conditions
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)
Eligibility
Inclusion Criteria4
- 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 Criteria1
- Patient's clear unability or unwillingness to participate in follow-up examinations
Interventions
The Ennovate® Complex Spinal System is a posterior stabilization for the Complex and upper-thoracic spine. The implants are used for the posterior multisegmental correction and stabilization over all sections of the spine.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05281757