Status:
TERMINATED
Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery
Lead Sponsor:
NYU Langone Health
Conditions:
Dysphagia After Anterior Cervical Decompression and Fusion of the Spine
Eligibility:
All Genders
21-65 years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, placebo-controlled study to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients.
Detailed Description
The purpose of this randomized, double-blind, placebo-controlled study is to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia ...
Eligibility Criteria
Inclusion
- The subjects included in the study are patients undergoing an anterior cervical spine procedure.
Exclusion
- Patients with greater than ASA grade II will be excluded. Patients with non-degenerative conditions, such as trauma, tumors, infection, radiation, and diabetes will be excluded. Patients with posterior procedures will be excluded. Patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on the EAT-10 questionnaire,19 will also be excluded. Patients who are pregnant will be excluded from this study.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02266797
Start Date
November 1 2013
End Date
September 1 2015
Last Update
October 25 2018
Active Locations (3)
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1
Center for Musculoskeletal Care (CMC)
New York, New York, United States, 10016
2
NYU Langone Medical Center
New York, New York, United States, 10016
3
NY Spine Institute
Westbury, New York, United States, 11590