Multicentric Registry for the Detection of C5 Palsy After Anterior Cervical Discectomy and Fusion

NCT ID: NCT02875431

Last Updated: 2016-08-23

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

UNKNOWN

Total Enrollment

1087 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-11-30

Brief Summary

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Detect the reason for the frequently occurring C5 palsy after anterior cervical discectomy and fusion

Detailed Description

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A registry which includes all known and individually analyzed but even new factors are evaluated in order to perform a multivariate analysis for the detection of risk factors of C5 palsy after anterior cervical discectomy and fusion which is a very disabling and still cryptic complication.

Conditions

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Degenerative Cervical Spinal Stenosis Cervical Disc Herniation Suspected Cervical Spine Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ACDF or cervical vertebral body replacement

Patients undergo ACDF or cervical vertebral body replacement

Intervention Type PROCEDURE

Interventions

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Patients undergo ACDF or cervical vertebral body replacement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ACDF or cervical vertebral body replacement due to herniated disc, spinal stenosis or trauma

Exclusion Criteria

* infectious disease or neurodegenerative disease
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role collaborator

Klinik für Neurochirurgie, Köln-Mehrheim

UNKNOWN

Sponsor Role collaborator

Wirbelsäulenzentrum, St. Josephs-Hospital, Wiesbaden

UNKNOWN

Sponsor Role collaborator

Vivantes Clinic Neukölln

OTHER

Sponsor Role collaborator

Klinik für Neurochirurgie, Helios-Klinikum Krefeld

UNKNOWN

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

Klinikum Karlsbad-Langensteinbach

OTHER

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

Zentrum für Wirbelsäulenchirurgie Kempen

UNKNOWN

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernhard Meyer, MD

Role: STUDY_CHAIR

TU München

Locations

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Department of Neurosurgery

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sandro M Krieg, MD, MBA

Role: CONTACT

+498941409482

Sebastian Ille, MD

Role: CONTACT

+498941405693

Facility Contacts

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Sandro M Krieg, MD, MBA

Role: primary

Other Identifiers

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C5 registry

Identifier Type: -

Identifier Source: org_study_id

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