NCT02875431

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,087

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

August 12, 2016

Last Update Submit

August 17, 2016

Conditions

Degenerative Cervical Spinal StenosisCervical Disc HerniationSuspected Cervical Spine Instability

Outcome Measures

Primary Outcomes (1)

  • C5 palsy

    defined as deterioration on BMRC scale of C5 innervated muscles

    3 months

Study Arms (1)

ACDF or cervical vertebral body replacement

Procedure: Patients undergo ACDF or cervical vertebral body replacement

Interventions

Patients undergo ACDF or cervical vertebral body replacementPROCEDURE
ACDF or cervical vertebral body replacement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • infectious disease or neurodegenerative disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery

Munich, Bavaria, 81675, Germany

RECRUITING

Study Officials

  • Bernhard Meyer, MD

    TU München

    STUDY CHAIR

Central Study Contacts

Sandro M Krieg, MD, MBA

CONTACT

+498941409482sandro.krieg@tum.de

Sebastian Ille, MD

CONTACT

+498941405693sebastian.ille@tum.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 23, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

November 1, 2017

Last Updated

August 23, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)