Voice and Swallowing Outcomes Following Revision Anterior... | NCT01017055

Studies
Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery

NCT01017055

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Jan 16, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Dysphagia
Dysphonia

Interventions

Voice and Swallowing evaluations

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB-090409003	Other Identifier	UAB

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 26, 2009Actual

Primary Completion Date

Dec 25, 2025Actual

Completion Date

Jan 1, 2026Actual

First Submitted Date

Nov 4, 2009

First Submission Date that Met QC Criteria

Nov 19, 2009

First Posted Date

Nov 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2026

Last Update Posted Date

Jan 16, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kirk P. Withrow, MD, Associate Professor of Surgery, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Voice and Swallowing Evaluations			Other: Voice and Swallowing evaluations

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Voice and Swallowing evaluations	Other	Fiberoptic exam to evaluate vocal cord and swallowing function	Voice and Swallowing Evaluations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Quality of life as measured by a self-administered 10 point questionnaire.		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing revision anterior cervical spine surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William R Carroll, MD	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UAB		Birmingham	Alabama	35233	United States

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders
D055154	Dysphonia

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014831	Voice

Ancestor Terms

ID	Term
D012143	Respiratory Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided