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NCT02875431 Clinical Trial

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

Cervical Disc Herniation Clinical Trial

— C5registry  

Official title:
Registry for the Detection of C5 Palsy After ACDF

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02875431
Other study ID # C5 registry
Secondary ID
Status Recruiting
Phase N/A
First received August 12, 2016
Last updated August 17, 2016
Start date August 2016
Est. completion date November 2017

Study information
Verified date August 2016
Source Technische Universität München
Contact Sandro M Krieg, MD, MBA
Phone +498941409482
Email sandro.krieg@tum.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1087
Est. completion date November 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- infectious disease or neurodegenerative disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Patients undergo ACDF or cervical vertebral body replacement

Locations
Country Name City State
Germany Department of Neurosurgery Munich Bavaria

Sponsors (12)
Lead Sponsor Collaborator
Technische Universität München Charite University, Berlin, Germany, Klinik für Neurochirurgie, Helios-Klinikum Krefeld, Klinik für Neurochirurgie, Köln-Mehrheim, Klinik für Neurochirurgie, Vivantes Klinikum Neuköln, Berlin, Klinikum Karlsbad-Langensteinbach, Ludwig-Maximilians - University of Munich, Medical University Innsbruck, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Geneva, Wirbelsäulenzentrum, St. Josephs-Hospital, Wiesbaden, Zentrum für Wirbelsäulenchirurgie Kempen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary C5 palsy defined as deterioration on BMRC scale of C5 innervated muscles 3 months No
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