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PMCF Study on the Safety and Performance of CESPACE 3D

NCT ID: NCT04477447

Last Updated: 2024-12-19

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

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-21

Study Completion Date

2024-04-16

Brief Summary

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Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)

Detailed Description

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Conditions

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Degenerative Instability Spondylolisthesis Post-discectomy Syndrome Post-traumatic Instabilities

Keywords

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Cervical Vertebrae; Spondylolisthesis; Treatment Outcome; Interbody Fusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient is minimum 18 years old
* Written informed consent for the documentation of clinical and radiological results
* Patient's indication according to IFU
* Patient is not pregnant

Exclusion Criteria

• Patient is not willing or able to participate at the follow-up examination
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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Stefan Nikolaus Kroppenstedt, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Abteilung für Wirbelsäulenchirurgie Sana Kliniken Sommerfeld

Francis Kilian, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Katholisches Klinikum Koblenz

Locations

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Katholisches Klinikum Koblenz

Koblenz, , Germany

Site Status

Sana Kliniken Sommerfeld

Kremmen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AAG-O-H-2004

Identifier Type: -

Identifier Source: org_study_id