RecruitingNCT05281757

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


Sponsor

Aesculap AG

Enrollment

200 participants

Start Date

Feb 18, 2022

Study Type

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

Plain Language Summary

Simplified for easier understanding

This is a post-market follow-up study to monitor the long-term safety and performance of the Ennovate® Complex — a spinal implant device used in spine surgery. The study simply collects clinical and imaging data from patients who have already received or will receive this device as part of their normal medical care. **You may be eligible if...** - You are 18 or older and have received (or are receiving) the Ennovate® Complex spinal device as part of your medical treatment - You have provided consent to share your medical records for follow-up - If under 18, both the patient and a parent/legal guardian have given consent **You may NOT be eligible if...** - You are clearly unwilling or unable to attend follow-up appointments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEposterior stabilization for the cervical spine

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)

University Hospital Brno

Brno, Czechia

Hospital Universiti Kebangsaan Malaysia (HUKM)

Kuala Lumpur, Malaysia

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NCT05281757


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