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Multicentric Registry for the Detection of C5 Palsy After Anterior Cervical Discectomy and Fusion (C5registry)

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ClinicalTrials.gov Identifier: NCT02875431
Recruitment Status : Unknown
Verified August 2016 by Technische Universität München.
Recruitment status was:  Recruiting
First Posted : August 23, 2016
Last Update Posted : August 23, 2016
Sponsor:
Collaborators:
Medical University Innsbruck
Charite University, Berlin, Germany
University Hospital, Geneva
Klinik für Neurochirurgie, Köln-Mehrheim
Wirbelsäulenzentrum, St. Josephs-Hospital, Wiesbaden
Klinik für Neurochirurgie, Vivantes Klinikum Neuköln, Berlin
Klinik für Neurochirurgie, Helios-Klinikum Krefeld
Universitätsklinikum Hamburg-Eppendorf
Klinikum Karlsbad-Langensteinbach
Ludwig-Maximilians - University of Munich
Zentrum für Wirbelsäulenchirurgie Kempen
Information provided by (Responsible Party):
Technische Universität München

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

Condition or disease Intervention/treatment
Degenerative Cervical Spinal Stenosis Cervical Disc Herniation Suspected Cervical Spine Instability Procedure: Patients undergo ACDF or cervical vertebral body replacement

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1087 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Registry for the Detection of C5 Palsy After ACDF
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Group/Cohort Intervention/treatment
ACDF or cervical vertebral body replacement Procedure: Patients undergo ACDF or cervical vertebral body replacement



Primary Outcome Measures :
  1. C5 palsy [ Time Frame: 3 months ]
    defined as deterioration on BMRC scale of C5 innervated muscles



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ACDF or cervical vertebral body replacement due to herniated disc, spinal stenosis or trauma
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • infectious disease or neurodegenerative disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875431


Contacts
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Contact: Sandro M Krieg, MD, MBA +498941409482 sandro.krieg@tum.de
Contact: Sebastian Ille, MD +498941405693 sebastian.ille@tum.de

Locations
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Germany
Department of Neurosurgery Recruiting
Munich, Bavaria, Germany, 81675
Contact: Sandro M Krieg, MD, MBA       sandro.krieg@tum.de   
Sponsors and Collaborators
Technische Universität München
Medical University Innsbruck
Charite University, Berlin, Germany
University Hospital, Geneva
Klinik für Neurochirurgie, Köln-Mehrheim
Wirbelsäulenzentrum, St. Josephs-Hospital, Wiesbaden
Klinik für Neurochirurgie, Vivantes Klinikum Neuköln, Berlin
Klinik für Neurochirurgie, Helios-Klinikum Krefeld
Universitätsklinikum Hamburg-Eppendorf
Klinikum Karlsbad-Langensteinbach
Ludwig-Maximilians - University of Munich
Zentrum für Wirbelsäulenchirurgie Kempen
Investigators
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Study Chair: Bernhard Meyer, MD TU München

Additional Information:

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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02875431     History of Changes
Other Study ID Numbers: C5 registry
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases