Furlow Palatoplasty With Tensor Tenopexy

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.

Study Overview

• Status: Completed
• Conditions: Cleft Palate; Otitis Media
• Intervention / Treatment: Procedure: palatoplasty

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 Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• patients with syndromic clefts or genetic abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Furlow palatoplasty; standard procedure	Procedure: palatoplasty; procedure to close cleft palate
Experimental: modified Furlow palatoplasty; standard procedure plus modification	Procedure: palatoplasty; procedure to close cleft palate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hearing status	results of audiometric testing	3-year visit
otitis media status	diagnosis of OM, presence/absence of ventilation tubes at time of 3-year visit	3 years of age
Eustachian tube function (ETF) measures	ETF test results	3-year visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Weighted Speech Score	obtained as standard of care	3 years of age
nasalence ratio	obtained as standard of care	3 years of age
McKay-Kummer SMAP test	obtained as standard of care	3 years of age
duration of speech therapy		by age 7 years
need for revision palatoplasties		by 7 years of age

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Cuneyt M Alper, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2012
• Primary Completion (Actual): December 23, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: February 7, 2012
• First Submitted That Met QC Criteria: February 14, 2012
• First Posted (Estimate): February 17, 2012

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: cleft palate; otitis media
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Ear Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Otitis; Otitis Media
• Other Study ID Numbers: PRO11060248; R01DC011524 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No