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

• Conditions: Degenerative Cervical Spinal Stenosis; Cervical Disc Herniation; Suspected Cervical Spine Instability
• Interventions: Procedure: Patients undergo ACDF or cervical vertebral body replacement

• Registration Number: NCT02875431
• Lead Sponsor: Technical University of Munich

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 Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-17
• Last Update Submitted: 2016-08-17
• Study First Posted: 2016-08-23
• Last Update Posted: 2016-08-23
• Primary Completion: 2017-08
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1087

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ACDF or cervical vertebral body replacement	Patients undergo ACDF or cervical vertebral body replacement	-

Primary Outcome Measures

Name	Time	Method
C5 palsy	3 months	defined as deterioration on BMRC scale of C5 innervated muscles

Trial Locations

Locations (1)

Department of Neurosurgery; 🇩🇪 Munich, Bavaria, Germany