Otitis MediaNCT01535131
Furlow Palatoplasty With Tensor Tenopexy
A study testing palatoplasty in people with Otitis Media and Cleft Palate, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study compares a standard method for palate repair (the Furlow palatoplasty) with a modification of that method to determine which, if either, is more effective in reducing the duration of middle-ear disease (fluid in the ear) in cleft palate patients. Read more about this study
- Who is it for?
- Ages Up to 15 months
- Conditions the study is for
- Otitis Media, Cleft Palate
- What is being tested?
- palatoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2012to 30 Jun 2020
- Phase
- Interventional
- 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 Up to 15 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- cleft palate with or without cleft lip classified as Veau I through IV
- parental consent for procedure
- patients assigned to Drs. Losee, Davit, Grundwaldt, or Goldstein for palatoplasty
- children up to 15 months of age who have not had palatoplasty but have tympanostomy tubes
Who cannot join
- patients with syndromic clefts or genetic abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Furlow Palatoplasty With Tensor Tenopexy for Otitis Media
This study compares a standard method for palate repair (the Furlow palatoplasty) with a modification of that method to determine which, if either, is more effective in reducing the duration of middle-ear disease (fluid in the ear) in cleft palate patients.
Read the detailed description
Almost all infants and young children who were born with a cleft palate (with or without a cleft lip) have middle-ear disease and this condition can last into late childhood and early adolescence. The type of middle-ear disease that usually occurs in cleft palate patients is not associated with pain or symptoms, but the fluid in the middle-ear causes poor hearing and sometimes problems with balance.
Past studies show that the middle-ear disease in infants and children with cleft palate is caused by their inability to open a natural tube that connects the back of the nose with the middle-ear (called the Eustachian tube). Opening the Eustachian tube is required to keep the pressure in the middle-ear equal to that of the atmosphere which prevents fluid from building up in the middle-ear. For this reason, middle-ear disease is usually treated by placing a small plastic tube in the eardrum which keeps the middle-ear pressure and pressure in the room (atmospheric pressure) equal even when the Eustachian tube fails to open. However, the disease often returns when the plastic tube becomes blocked or falls out and a new tube needs to be placed in the eardrum. The actions of two small muscles, the levator veli palatini (LVP) muscle and the tensor veli palatini (TVP) muscle combine to open the Eustachian tube and the LVP muscle plays a role in raising the palate during speech, swallowing and other activities. Both muscles run through the soft palate. In children with cleft palate, the usual position, orientation and function of both of these muscles are abnormal and few surgical procedures for palate repair focus on re-establishing a more "normal" orientation and attachment of these muscles.
One well accepted method for repair of the palate, the Furlow palatoplasty is the standard procedure used by the two cleft palate surgeons involved in this study. During the Furlow palatoplasty the attachment of the TVP muscle is cut. Recently, a modification of the Furlow palatoplasty, called a tensor tenopexy, has been described that involves attaching the cut part of the TVP muscle to a bony hook in the soft palate in an effort to improve Eustachian tube function and lead to less middle-ear disease. One small study presented results suggesting that middle-ear disease was cured at an earlier age in those cleft palate patients who had their palates repaired using the modified Furlow procedure when compared to a number of other methods of palate repair, but these comparisons did not include the standard Furlow procedure. However, the design of that study was poor and the possible benefits of this small modification in the surgical procedure with respect to middle-ear disease need to be evaluated in a more formal study. Because the surgical procedures for the Furlow palatoplasty and the modified Furlow procedure are identical with the exception of the addition of anchoring the cut muscle attachment, a study of these two procedures will allow us to determine if the modified procedure does or does not improve middle-ear disease at an earlier age in patients with cleft palate.
- Conditions
- Otitis Media, Cleft Palate
- Being tested
- palatoplasty
- Keywords
- otitis media, cleft palate
- Medical subject headings
- Otitis Media, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palatoplastyProcedure or surgery
procedure to close cleft palate
| Study group | Role | What they receive |
|---|---|---|
| Furlow palatoplasty | Active comparator | standard procedure Receives: Procedure: palatoplasty |
| modified Furlow palatoplasty | Experimental | standard procedure plus modification Receives: Procedure: palatoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
hearing status
results of audiometric testing
Measured: 3-year visit
otitis media status
diagnosis of OM, presence/absence of ventilation tubes at time of 3-year visit
Measured: 3 years of age
Eustachian tube function (ETF) measures
ETF test results
Measured: 3-year visit
Secondary outcomes (5)
Pittsburgh Weighted Speech Score
obtained as standard of care
Measured: 3 years of age
nasalence ratio
obtained as standard of care
Measured: 3 years of age
McKay-Kummer SMAP test
obtained as standard of care
Measured: 3 years of age
duration of speech therapy
Measured: by age 7 years
need for revision palatoplasties
Measured: by 7 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study start28 Feb 2012
- Primary completion23 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Cuneyt M. Alper, University of Pittsburgh
- Investigators
- Cuneyt M Alper, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535131
- Sponsor's protocol ID
- PRO11060248
- Other IDs
- R01DC011524
- Status last verified
- Jul 2022
- First submitted
- 7 Feb 2012
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Alper CM, Teixeira MS, Mandel EM, Swarts JD, Losee JE. Tensor Veli Palatini Muscle Tenopexy During Furlow Palatoplasty Fails to Improve Otologic Outcomes: A Randomized Clinical Trial. Cleft Palate Craniofac J. 2026 Apr 3:10556656261438891. doi: 10.1177/10556656261438891. Online ahead of print.
PubMed 41930721
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furlow Palatoplasty With Tensor Tenopexy for Otitis Media
- ClinicalTrials.gov ID
- NCT01535131
- Acronym / sponsor ID
- PRO11060248
- Conditions
- Otitis Media, Cleft Palate
- Keywords
- otitis media, cleft palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 28 Feb 2012 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 17 Feb 2012 (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.
This study compares a standard method for palate repair (the Furlow palatoplasty) with a modification of that method to determine which, if either, is more effective in reducing the duration of middle-ear disease (fluid in the ear) in cleft palate patients.
Detailed description
Almost all infants and young children who were born with a cleft palate (with or without a cleft lip) have middle-ear disease and this condition can last into late childhood and early adolescence. The type of middle-ear disease that usually occurs in cleft palate patients is not associated with pain or symptoms, but the fluid in the middle-ear causes poor hearing and sometimes problems with balance.
Past studies show that the middle-ear disease in infants and children with cleft palate is caused by their inability to open a natural tube that connects the back of the nose with the middle-ear (called the Eustachian tube). Opening the Eustachian tube is required to keep the pressure in the middle-ear equal to that of the atmosphere which prevents fluid from building up in the middle-ear. For this reason, middle-ear disease is usually treated by placing a small plastic tube in the eardrum which keeps the middle-ear pressure and pressure in the room (atmospheric pressure) equal even when the Eustachian tube fails to open. However, the disease often returns when the plastic tube becomes blocked or falls out and a new tube needs to be placed in the eardrum. The actions of two small muscles, the levator veli palatini (LVP) muscle and the tensor veli palatini (TVP) muscle combine to open the Eustachian tube and the LVP muscle plays a role in raising the palate during speech, swallowing and other activities. Both muscles run through the soft palate. In children with cleft palate, the usual position, orientation and function of both of these muscles are abnormal and few surgical procedures for palate repair focus on re-establishing a more "normal" orientation and attachment of these muscles.
One well accepted method for repair of the palate, the Furlow palatoplasty is the standard procedure used by the two cleft palate surgeons involved in this study. During the Furlow palatoplasty the attachment of the TVP muscle is cut. Recently, a modification of the Furlow palatoplasty, called a tensor tenopexy, has been described that involves attaching the cut part of the TVP muscle to a bony hook in the soft palate in an effort to improve Eustachian tube function and lead to less middle-ear disease. One small study presented results suggesting that middle-ear disease was cured at an earlier age in those cleft palate patients who had their palates repaired using the modified Furlow procedure when compared to a number of other methods of palate repair, but these comparisons did not include the standard Furlow procedure. However, the design of that study was poor and the possible benefits of this small modification in the surgical procedure with respect to middle-ear disease need to be evaluated in a more formal study. Because the surgical procedures for the Furlow palatoplasty and the modified Furlow procedure are identical with the exception of the addition of anchoring the cut muscle attachment, a study of these two procedures will allow us to determine if the modified procedure does or does not improve middle-ear disease at an earlier age in patients with cleft palate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furlow palatoplasty | Active comparator | Procedure: palatoplastystandard procedure |
| modified Furlow palatoplasty | Experimental | Procedure: palatoplastystandard procedure plus modification |
Who may qualify
- Ages
- Up to 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- cleft palate with or without cleft lip classified as Veau I through IV
- parental consent for procedure
- patients assigned to Drs. Losee, Davit, Grundwaldt, or Goldstein for palatoplasty
- children up to 15 months of age who have not had palatoplasty but have tympanostomy tubes
Key exclusion criteria (1 listed)
- patients with syndromic clefts or genetic abnormalities
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 |
|---|---|---|
| palatoplastyprocedure to close cleft palate | Procedure or surgery | Furlow palatoplasty, modified Furlow palatoplasty |
Primary outcome
hearing status
Time frame: 3-year visit
results of audiometric testing
otitis media status
Time frame: 3 years of age
diagnosis of OM, presence/absence of ventilation tubes at time of 3-year visit
Eustachian tube function (ETF) measures
Time frame: 3-year visit
ETF test results
5 secondary outcomes
Pittsburgh Weighted Speech Score
Time frame: 3 years of age
nasalence ratio
Time frame: 3 years of age
McKay-Kummer SMAP test
Time frame: 3 years of age
duration of speech therapy
Time frame: by age 7 years
need for revision palatoplasties
Time frame: by 7 years of age
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 1 Aug 2022.
- Derived from this study: PubMed 41930721Alper CM, Teixeira MS, Mandel EM, Swarts JD, Losee JE. Tensor Veli Palatini Muscle Tenopexy During Furlow Palatoplasty Fails to Improve Otologic Outcomes: A Randomized Clinical Trial. Cleft Palate Craniofac J. 2026 Apr 3:10556656261438891. doi: 10.1177/10556656261438891. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Cuneyt M Alper, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing palatoplasty in people with Otitis Media and Cleft Palate, run by University of Pittsburgh 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 4 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 1 Aug 2022. 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?
hearing status (time frame: 3-year visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01535131, which also lists 1 linked publication.
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 1 Aug 2022.