Multicentric Registry for the Detection of C5 Palsy After... | NCT02875431

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Aug 2017Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

Aug 12, 2016

First Submission Date that Met QC Criteria

Aug 17, 2016

First Posted Date

Aug 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2016

Last Update Posted Date

Aug 23, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Technical University of MunichOTHER

Collaborators

Name	Class
Medical University Innsbruck	OTHER
Charite University, Berlin, Germany	OTHER
University Hospital, Geneva	OTHER
Klinik für Neurochirurgie, Köln-Mehrheim

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,087Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACDF or cervical vertebral body replacement			Procedure: Patients undergo ACDF or cervical vertebral body replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients undergo ACDF or cervical vertebral body replacement	Procedure		ACDF or cervical vertebral body replacement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sandro M Krieg, MD, MBA	Contact	+498941409482		sandro.krieg@tum.de
Sebastian Ille, MD	Contact	+498941405693		sebastian.ille@tum.de

Overall Officials

Name	Affiliation	Role
Bernhard Meyer, MD	TU München	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurosurgery	Recruiting	Munich	Bavaria	81675	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.