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

NCT ID: NCT03550846

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-12

Study Completion Date

2022-11-18

Brief Summary

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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.

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Detailed Description

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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

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Spinal Fusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carolin Meyer, Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Orthopädie und Unfallchirurgie der Universitätsklinik Köln

Locations

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APEX Spine Wirbelsäulenpraxis

München, Bavaria, Germany

Site Status

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status

Carolin Meyer

Cologne, , Germany

Site Status

Klinik und Poliklinik für Neurochirurgie

Göttingen, , Germany

Site Status

Katholisches Klinikum Koblenz

Koblenz, , Germany

Site Status

medius Klinik

Nürtingen, , Germany

Site Status

Praxis für Neurochirurgie am Klinikum

Tuttlingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AAG-O-H-1639

Identifier Type: -

Identifier Source: org_study_id

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