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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

Tracking Information
First Submitted Date August 12, 2016
First Posted Date August 23, 2016
Last Update Posted Date August 23, 2016
Study Start Date August 2016
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2016)
C5 palsy [ Time Frame: 3 months ]
defined as deterioration on BMRC scale of C5 innervated muscles
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multicentric Registry for the Detection of C5 Palsy After Anterior Cervical Discectomy and Fusion
Official Title Registry for the Detection of C5 Palsy After ACDF
Brief Summary Detect the reason for the frequently occurring C5 palsy after anterior cervical discectomy and fusion
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ACDF or cervical vertebral body replacement due to herniated disc, spinal stenosis or trauma
Condition
  • Degenerative Cervical Spinal Stenosis
  • Cervical Disc Herniation
  • Suspected Cervical Spine Instability
Intervention Procedure: Patients undergo ACDF or cervical vertebral body replacement
Study Groups/Cohorts ACDF or cervical vertebral body replacement
Intervention: Procedure: Patients undergo ACDF or cervical vertebral body replacement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 17, 2016)
1087
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • infectious disease or neurodegenerative disease
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02875431
Other Study ID Numbers C5 registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Technische Universität München
Study Sponsor Technische Universität München
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
Investigators
Study Chair: Bernhard Meyer, MD TU München
PRS Account Technische Universität München
Verification Date August 2016