Status:

UNKNOWN

The Collar Post Anterior Cervical Spine Surgery Study

Lead Sponsor:

Unity Health Toronto

Conditions:

Cervical Radiculopathy

Cervical Myelopathy

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy seco...

Detailed Description

The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy seco...

Eligibility Criteria

Inclusion

  • between the ages of 18 and 80;
  • presenting with cervical radiculopathy and/or myelopathy to one of the study centers;
  • deemed appropriate by the attending surgeon involved for a one, two or three level plated ACDF or a one-level ACDF with a standalone interbody cage; and
  • able to cooperate in the completion of all study consents, forms and documents. 5. Participants who are able to speak, read and write at an elementary school level

Exclusion

  • those with previous cervical surgery;
  • those undergoing single or multi-level plated ACDF for a diagnosis related to malignancy, infection or trauma;
  • those undergoing a single or multi-level plated ACDF augmented with a posterior cervical fusion or posterior cervical decompression and fusion;
  • those undergoing a multi-level non-plated ACDF;
  • those undergoing ACDF at greater than three levels, and;
  • those with a pre-existent neurological or mental disorder which would preclude accurate evaluation and follow-up.

Key Trial Info

Start Date :

February 23 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2021

Estimated Enrollment :

244 Patients enrolled

Trial Details

Trial ID

NCT03842072

Start Date

February 23 2018

End Date

July 1 2021

Last Update

September 18 2019

Active Locations (2)

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Page 1 of 1 (2 locations)

1

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

2

Hôpital Général de Montréal Montreal General Hospital

Montreal, Quebec, Canada, H3G 1A4