CompletedNot Applicable

Clinical and Radiological Investigation of a New Spinal Fixateur Interne (Ennovate®)

Germany188 participantsStarted 2018-04-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change of Clinical Results from Preoperative Status to Follow-Up at 12 Months

Timeframe: preoperative, 12 months postoperative

Trial details

NCT IDNCT03550846

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-05-27

View on ClinicalTrials.gov More Spinal Fusion trials