Magnetic Mini-Mover Procedure to Treat Pectus Excavatum

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.

Conditions

• Pectus Excavatum

Interventions

DEVICE

Magnetic Mini-Mover Procedure (3MP)

A rare earth magnet encased in FDA-approved titanium will be implanted securely on the outer surface of the lower end of the sternum in patients with pectus excavatum. This is accomplished as an outpatient procedure, under brief general anesthesia. A 2-inch transverse skinline incision is made at the junction of the sternum and xyphoid and the space in front and behind the sternum is dissected bluntly. The titanium can containing the magnet is securely fixed to the sternum by screwing it into a titanium fixation disk in front of the sternum. The procedure takes 1/2-hour, and the patient can go home the same day. In another outpatient procedure, the Magnimplant is explanted 18 months after implantation.

DEVICE

Magnatract (external magnet in a removable external brace)

An external orthotic device "Magnatract" which includes an external magnet in a removable brace is fitted specifically to the patient's chest wall deformity. A calibrated meter in the external device measures the force applied between the two magnets. When the patient and family are comfortable with the device and comfort and skin condition have been assessed, the patient will be allowed to take the Magnatract home and begin the process of gradually advancing the sternum forward as the abnormal costal cartilage is reformed.

PROCEDURE

3MP (Magnetic Mini-Mover Procedure)

* Subject has EKG performed to measure baseline cardiac activity. * Magnimplant is implanted. * After one week, "Magnatract" is fitted. * Chest x-ray and 2nd EKG performed 30 days post-implantation. * Patient and parents complete QoL questionnaire 30d post-implantation. * Patient seen weekly for first month post-implantation to assess comfort and skin condition. Thereafter, will be seen monthly. * At each monthly visit, patient will have lateral and anterior-posterior chest X-rays to monitor sternal correction. * At each visit data logger is downloaded to measure strength of pull since last visit and amount of wear-time. * Magnimplant explanted 18 months later as 1/2-hr outpatient procedure. * CT scan and third EKG performed after explanation. * Patient and parents complete QOL questionnaires after explantation and 1 yr post-explantation.

Sponsors & Collaborators

• FDA Office of Orphan Products Development

  collaborator FED

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Michael R Harrison, MD · University of California, San Francisco Medical Center and Children's Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

8 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2010-05-31

Completion

2011-04-30

Countries

• United States

Study Locations