Monitoring the safety and performance of Ennovate® Complex for scoliosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects data on the safety and performance of the Ennovate® Complex system used for treating various spinal deformities, including scoliosis. It involves multiple centers across different countries and focuses on documenting clinical and radiological outcomes for patients who have undergone posterior stabilization for the cervical spine. The study aims to provide valuable insights into the effectiveness of the implant system in real-world settings, ensuring ongoing safety monitoring post-market.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Universiti Kebangsaan Malaysia (HUKM)
  Kuala Lumpur, Malaysia Recruiting
• University Hospital Brno
  Brno, Czechia Suspended

Study contacts

• Principal investigator: Mohd Hisam, Prof. Dr. — Hospital Universiti Kebangsaan Malaysia (HUKM)
• Study coordinator: Sarah Mattes
• Email: sarah.mattes@aesculap.de
• Phone: +497461950

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Morning bright light therapy to slow or prevent adolescent idiopathic scoliosis

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• Characterization of Visual Perception Impairments in Idiopathic Scoliosis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.