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

August 17, 2016 updated by: Technical University of Munich

Registry for the Detection of C5 Palsy After ACDF

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1087

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Recruiting
        • Department of Neurosurgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • infectious disease or neurodegenerative disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C5 palsy
Time Frame: 3 months
defined as deterioration on BMRC scale of C5 innervated muscles
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

Charite University, Berlin, Germany
University Hospital, Geneva
Ludwig-Maximilians - University of Munich
Medical University Innsbruck
Universitätsklinikum Hamburg-Eppendorf
Vivantes Clinic Neukölln
Klinikum Karlsbad-Langensteinbach
Klinik für Neurochirurgie, Köln-Mehrheim
Wirbelsäulenzentrum, St. Josephs-Hospital, Wiesbaden
Klinik für Neurochirurgie, Helios-Klinikum Krefeld
Zentrum für Wirbelsäulenchirurgie Kempen

Investigators

  • Study Chair: Bernhard Meyer, MD, TU München

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C5 registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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