Clinical and Radiological Investigation of a New Spinal Fixateur Interne (Ennovate®) (TENNIS)
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Conditions
Details and patient eligibility
About
This study is planned and conducted to document all patients in the participating Centers, who are treated with the CE-marked product, the Fixateur Ennovate®, regardless of the diagnosis or indication. Data on performance and safety of the product, validated patient based questionnaires (Oswestry Disability Index, ODI) as well as the satisfaction of the patients in general are captured.
Full description
The list of spinal treatments is growing, and healthcare authorities today are at times limiting their access due to a lack of evidence of safety and efficiency.
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 trauma and degenerative disorders.
Enrollment
Sex
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Volunteers
Inclusion criteria
- Consent in the documentation of clinical and radiological results
Exclusion criteria
- If it is clear that the patient cannot participate in a follow-up examination, he will be excluded from the study documentation.
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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