Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAesculap AG
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Patient's clear unability or unwillingness to participate in follow-up examinations
Trial design
Treatments tested in this trial
- posterior stabilization for the cervical spine
Treatment groups
200 Participants
are divided into 1 treatment groupLocations
2Czechia
University Hospital Brno62500, Brno Czechia
Malaysia
Hospital Universiti Kebangsaan Malaysia (HUKM) Kuala Lumpur Malaysia
Sponsors and collaborators
Aesculap AG
Lead sponsor
Raylytic GmbH
Collaborator
Source ClinicalTrials.gov