Trials / Completed
CompletedNCT03550846
Clinical and Radiological Investigation of a New Spinal Fixateur Interne (Ennovate®)
Total Indications Ennovate® Non-Interventional Study on Clinical and Radiological Results With Pedicle Screw Fixation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 188 (actual)
- Sponsor
- Aesculap AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
Timeline
- Start date
- 2018-04-12
- Primary completion
- 2021-05-27
- Completion
- 2022-11-18
- First posted
- 2018-06-08
- Last updated
- 2023-01-17
Locations
7 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03550846. Inclusion in this directory is not an endorsement.