Clinical Trial: Magnetic Mini-Mover Procedure to Treat Pectus Excavatum

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Magnetic Alteration of Pectus Excavatum

Brief Summary:

This is a medical research study.

The study investigators have developed a method to gradually repair pectus excavatum (sunken chest) deformity by placing a magnet on the sternum (breastbone) and then applying an external magnetic force that will pull the sternum outward gradually.

Potential candidates for this study are children and adolescents with a previously diagnosed congenital pectus excavatum (sunken chest) deformity who are otherwise healthy and are seeking corrective surgery for their condition. They will be residents of the U.S. and between the ages of 8 and 14 years of age. Potential candidates and their families will have already been counseled about this condition and about the standard way to repair this deformity.

The purpose of this study is to test what effects, good and/or bad, placing an external/internal magnetic device has on correcting pectus excavatum deformity in children, and the safety of using such a device for treatment.


Detailed Summary:

Pectus excavatum is the most common congenital chest wall abnormality in children. Surgical correction requires a big operation under general anesthesia which forces the sternum forward and holds it in place using a metal chest wall strut. Deformation of the chest wall under great pressure may result in complications and potential relapses as well as postoperative pain requiring hospitalization for regional and narcotic anesthesia for up to a week. An alternative principle for correction of chest wall and other deformities is gradual (bit-by-bit) correction using minimal force applied over many months (like moving teeth with orthodontic braces).

The hypothesis of this study is that constant outward force on the deformed cartilage in pectus excavatum will produce biologic reformation of cartilage and correction of the chest wall deformity.

The study investigators have developed a novel method of achieving gradual deformation/reformation of chest wall cartilage without the need for transdermal orthopedic devices or repeated surgeries. A magnetic force field is used to apply controlled, sustained force to promote biologic reformation of structural cartilage (the same principle as distraction osteogenesis). A magnet is implanted on the sternum and secured using a novel fixation strategy that can be accomplished through a 3-cm subxyphoid incision as a brief outpatient procedure. The magnet (and sternum) is pulled outward by another magnet suspended in a novel, low-profile, lightweight device previously molded to the patient's anterior chest wall. The external magnet allows individual adjustment in small increments of the distance (and, thus, force) and orientation of the force applied to the sternum. The low-profile, non-obtrusive anterior chest wall prosthesis is held in place by the force field between the two magnets.

Sponsor: University of California, San Francisco

Current Primary Outcome:

  • Affect on Cardiac Activity [ Time Frame: One month post-explantation ]
    EKG performed prior to implantation, one month post-implantation, and after explanation to evaluate whether magnetic field near the heart adversely affects cardiac activity. Outcome measure describes number of patients who experienced adverse change in EKG.
  • Damage/Discoloration to Skin [ Time Frame: One-month post-explant ]
    Outcome measure is number of patients who experienced permanent skin damage or discoloration due to external brace wear
  • Efficacy: Patient Satisfaction [ Time Frame: One year post-explant ]
    Based on patient response to one-year post-explantation QoL questionnaire: How satisfied are you with the correction of your chest? Ratings: 5-very satisfied; 4-satisfied; 3-unsure; 2-dissatisfied; 1-very dissatisfied
  • Efficacy: Patient Recommendation of Treatment [ Time Frame: One year post-explanation ]
    Based on patient response to one-year post-explantation QoL statement: "I would recommend this treatment for pectus excavatum (sunken chest) to someone else with pectus excavatum." Ratings: 5-strongly agree; 4-agree; 3-unsure; 2-disagree; 1-strongly disagree


Original Primary Outcome:

  • Efficacy: Rate of correction by chest imaging and measurement of the Pectus Severity Index at baseline, one month post-implant, and post-magnet removal.
  • Safety: EKG will be performed prior to implantation, one month post-implantation, and after magnet is removed.


Current Secondary Outcome: Patient Compliance [ Time Frame: 18 months active Rx ]

Compliance measured by average number of hours per day external device was worn by patient, as measured by the data sensor and logging device built into external prosthetic


Original Secondary Outcome:

  • Patient Compliance: Data sensoring device will measure applied magnetic force as well as number of hours external device is worn by patient
  • Patient and family satisfaction: Quality-of-Life-type questionnaires will be administered one month after implantation, shortly after implant removal, and finally one year after implant removal.


Information By: University of California, San Francisco

Dates:
Date Received: April 24, 2007
Date Started: April 2007
Date Completion:
Last Updated: December 2, 2015
Last Verified: December 2015