Clinical and Radiological Investigation of a New Spinal Fixateur Interne (Ennovate®)
NCT03550846 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 188
Last updated 2023-01-17
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.
Conditions
- Spinal Fusion
Sponsors & Collaborators
-
Aesculap AG
lead INDUSTRY
Principal Investigators
-
Carolin Meyer, Dr. · Klinik für Orthopädie und Unfallchirurgie der Universitätsklinik Köln
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-12
- Primary Completion
- 2021-05-27
- Completion
- 2022-11-18
Countries
- Germany
Study Locations
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