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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT01535131
Study groupRoleWhat they receive
Furlow palatoplastyActive comparatorstandard procedure
Receives: Procedure: palatoplasty
modified Furlow palatoplastyExperimentalstandard procedure plus modification
Receives: Procedure: palatoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hearing status

    results of audiometric testing

    Measured: 3-year visit

  2. otitis media status

    diagnosis of OM, presence/absence of ventilation tubes at time of 3-year visit

    Measured: 3 years of age

  3. Eustachian tube function (ETF) measures

    ETF test results

    Measured: 3-year visit

Secondary outcomes (5)
  1. Pittsburgh Weighted Speech Score

    obtained as standard of care

    Measured: 3 years of age

  2. nasalence ratio

    obtained as standard of care

    Measured: 3 years of age

  3. McKay-Kummer SMAP test

    obtained as standard of care

    Measured: 3 years of age

  4. duration of speech therapy

    Measured: by age 7 years

  5. 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.

  1. First posted17 Feb 2012 (estimated)
  2. Study start28 Feb 2012
  3. Primary completion23 Dec 2019
  4. Study completion30 Jun 2020

Resources

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)
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

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.

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