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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2026
  • participants needed
    200
  • sponsor
    Aesculap AG
Updated on 1 May 2022

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)

Description

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.

Details
Condition Hyperkyphosis, Hyperlordosis, Congenital Scoliosis, Neuromuscular Scoliosis, Idiopathic Scoliosis
Treatment posterior stabilization for the cervical spine
Clinical Study IdentifierNCT05281757
SponsorAesculap AG
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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