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NCT01017055 Clinical Trial

Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery

Dysphagia Clinical Trial

Official title:
Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01017055
Other study ID # IRB-090409003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 26, 2009
Est. completion date June 2025

Study information
Verified date May 2024
Source University of Alabama at Birmingham
Contact Norma Miller, RN
Phone (205) 975-6169
Email ncmiller@uabmc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluate voice and swallowing outcomes post operatively.

Description:

Anterior Cervical Decompression and fusion is one of the most common spinal surgical procedures performed in the United States. Common complications of this type of surgery are difficulty swallowing and nerve dysfunction that can effect voice. The chance of having voice and swallowing disturbances increases if this type of surgery has to be repeated. The purpose of this study is to document the voice and swallowing function of patients undergoing this type of surgery in an effort to find better ways to identify and treat these common complications.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date June 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Patients undergoing revision anterior cervical spine surgery Exclusion Criteria: - Primary pathology of the upper aero-digestive tract other than mild chronic pharyngitis, pre-existing vocal cord paralysis.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Voice and Swallowing evaluations
Fiberoptic exam to evaluate vocal cord and swallowing function

Locations
Country Name City State
United States UAB Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vocal cord and swallowing function as measured by fiberoptic exam in the otolaryngology clinic pre-op and approximately 3 weeks post op. 4 weeks
Secondary Quality of life as measured by a self-administered 10 point questionnaire. 4 weeks
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