DysphagiaNCT01017055
Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery
An observational study of Dysphagia and Dysphonia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Evaluate voice and swallowing outcomes post operatively. Read more about this study
- Who is it for?
- Ages 19 years and older
- What is being tested?
- Voice and Swallowing evaluations
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2009to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing revision anterior cervical spine surgery
Who may be able to join
- Patients undergoing revision anterior cervical spine surgery
Who cannot join
- Primary pathology of the upper aero-digestive tract other than mild chronic pharyngitis, pre-existing vocal cord paralysis.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate voice and swallowing outcomes post operatively.
Read the 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.
- Being tested
- Voice and Swallowing evaluations
- Medical subject headings
- Deglutition Disorders, Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice and Swallowing evaluationsOther
Fiberoptic exam to evaluate vocal cord and swallowing function
| Study group | Role | What they receive |
|---|---|---|
| Voice and Swallowing Evaluations | Not described Receives: Other: Voice and Swallowing evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal cord and swallowing function as measured by fiberoptic exam in the otolaryngology clinic pre-op and approximately 3 weeks post op.
Measured: 4 weeks
Secondary outcomes (1)
Quality of life as measured by a self-administered 10 point questionnaire.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study start26 Oct 2009
- Primary completion25 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirk P. Withrow, MD, University of Alabama at Birmingham
- Investigators
- William R Carroll, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017055
- Sponsor's protocol ID
- IRB-090409003
- Other IDs
- IRB-090409003
- Status last verified
- Jan 2026
- First submitted
- 4 Nov 2009
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery
- ClinicalTrials.gov ID
- NCT01017055
- Acronym / sponsor ID
- IRB-090409003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 26 Oct 2009 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voice and Swallowing Evaluations | – | Other: Voice and Swallowing evaluations |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing revision anterior cervical spine surgery
Key inclusion criteria (1 listed)
- Patients undergoing revision anterior cervical spine surgery
Key exclusion criteria (1 listed)
- Primary pathology of the upper aero-digestive tract other than mild chronic pharyngitis, pre-existing vocal cord paralysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice and Swallowing evaluationsFiberoptic exam to evaluate vocal cord and swallowing function | Other | Voice and Swallowing Evaluations |
Primary outcome
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
1 secondary outcome
Quality of life as measured by a self-administered 10 point questionnaire.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William R Carroll, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia and Dysphonia, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.