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Clinical Trials/NCT01017055
NCT01017055CompletedNot Applicable

Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery

University of Alabama at Birmingham1 site in 1 country200 target enrollmentStarted: October 26, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
200
Locations
1
Primary Endpoint
Vocal cord and swallowing function as measured by fiberoptic exam in the otolaryngology clinic pre-op and approximately 3 weeks post op.

Study Overview

Brief Summary

Evaluate voice and swallowing outcomes post operatively.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Voice and Swallowing Evaluations

Intervention: Voice and Swallowing evaluations (Other)

Outcomes

Primary Outcomes

Vocal cord and swallowing function as measured by fiberoptic exam in the otolaryngology clinic pre-op and approximately 3 weeks post op.

Time Frame: 4 weeks

Secondary Outcomes

  • Quality of life as measured by a self-administered 10 point questionnaire.(4 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kirk P. Withrow, MD

Associate Professor of Surgery

University of Alabama at Birmingham

Study Sites (1)

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