Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex (COSINE)
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- STATUS
- Recruiting
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- End date
- Oct 1, 2026
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- participants needed
- 200
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- sponsor
- Aesculap AG
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 Identifier | NCT05281757 |
| Sponsor | Aesculap AG |
| Last Modified on | 1 May 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf 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.
Learn moreComplete 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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