Furlow Palatoplasty With Tensor Tenopexy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cuneyt M. Alper, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01535131
First received: February 7, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Otitis Media
Cleft Palate
Procedure: palatoplasty
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Furlow Palatoplasty With Tensor Tenopexy for Otitis Media

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • hearing status [ Time Frame: 3-year visit ] [ Designated as safety issue: No ]
    results of audiometric testing

  • otitis media status [ Time Frame: 3 years of age ] [ Designated as safety issue: No ]
    diagnosis of OM, presence/absence of ventilation tubes at time of 3-year visit

  • Eustachian tube function (ETF) measures [ Time Frame: 3-year visit ] [ Designated as safety issue: No ]
    ETF test results


Secondary Outcome Measures:
  • Pittsburgh Weighted Speech Score [ Time Frame: 3 years of age ] [ Designated as safety issue: Yes ]
    obtained as standard of care

  • nasalence ratio [ Time Frame: 3 years of age ] [ Designated as safety issue: Yes ]
    obtained as standard of care

  • McKay-Kummer SMAP test [ Time Frame: 3 years of age ] [ Designated as safety issue: No ]
    obtained as standard of care

  • duration of speech therapy [ Time Frame: by age 7 years ] [ Designated as safety issue: No ]
  • need for revision palatoplasties [ Time Frame: by 7 years of age ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: February 2012
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cleft palate with or without cleft lip classified as Veau I through IV
  • parental consent for procedure
  • patients assigned to Dr. Losee, Dr. Davit or Dr. Grundwaldt 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535131

Contacts
Contact: James Seroky, MS 412-692-5463 james.seroky@chp.edu

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: James Seroky, MS    412-692-5463    james.seroky@chp.edu   
Contact: Ellen Mandel, MD    412-692-5463    mandele@pitt.edu   
Principal Investigator: Cuneyt M Alper, MD         
Principal Investigator: Joseph Losee, MD         
Sub-Investigator: William J Doyle, PhD         
Sub-Investigator: Franklyn P Cladis, MD         
Sub-Investigator: Lorelei J Grundwaldt, MD         
Sub-Investigator: Ellen M Mandel, MD         
Sub-Investigator: Margaretha L Casselbrant, MD, PhD         
Sub-Investigator: Douglas Swarts, PhD         
Sub-Investigator: Alexander J Davit III, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Cuneyt M Alper, MD Children's Hospital of Pittsburgh
  More Information

No publications provided

Responsible Party: Cuneyt M. Alper, Professor of Otolaryngology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01535131     History of Changes
Other Study ID Numbers: PRO11060248, R01DC011524
Study First Received: February 7, 2012
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
otitis media
cleft palate

Additional relevant MeSH terms:
Jaw Diseases
Cleft Palate
Otitis
Otitis Media
Jaw Abnormalities
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 10, 2014