Magnetic Mini-Mover Procedure to Treat Pectus Excavatum (3MP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Harrison, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00466206
First received: April 24, 2007
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Pectus Excavatum
Device: Magnetic Mini-Mover Procedure (3MP)
Device: Magnatract (external magnet in a removable external brace)
Procedure: 3MP (Magnetic Mini-Mover Procedure)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Magnetic Alteration of Pectus Excavatum

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Affect on Cardiac Activity [ Time Frame: One month post-explantation ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Patient Compliance [ Time Frame: 18 months active Rx ] [ Designated as safety issue: No ]
    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


Enrollment: 10
Study Start Date: April 2007
Study Completion Date: April 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3MP - Treatment Arm
Magnetic Mini-Mover Procedure using the Magnimplant and Magnatract
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.

Other Name: 3MP
Device: Magnatract (external magnet in a removable external brace)
An external orthotic device "Magnatract" 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.
Other Name: Magnetic Mini-mover
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.
Other Name: 3MP

Detailed Description:

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.

The study objectives are to test the safety and probable benefit of this procedure in 10 otherwise healthy, young patients, between 8 years and 14 years of age, who have chosen to have this deformity corrected using this novel technique rather than the standard Ravitch or Nuss techniques. We will document the rate of correction by chest imaging and measurement of the Pectus Severity Index. The study investigators will document safety and efficacy with an EKG prior to implantation, one month post-implantation, and finally after the magnet is removed, as well as patient and family satisfaction with a post-procedure Quality of Life-type survey.

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Residents of the United States with previously diagnosed pectus excavatum who are referred to the UCSF Pediatric Surgery Service for evaluation and treatment will be considered for participation in this study. Only patients with moderate to severe pectus excavatum who meet all the inclusion criteria will participate. The patient and family will be fully counseled and consented about the risks and benefits of participation in the study, and will be asked to sign an informed consent reviewed and approved by the UCSF Committee on Human Research.

Inclusion Criteria:

  1. Resident of the U.S.;
  2. Otherwise healthy male or female with pectus excavatum deformity;
  3. Between 8 and 14 years of age;
  4. Pectus Severity Index > 3.5 (normal 2.56); and
  5. Ability to read and speak English.

Exclusion Criteria:

  1. Other congenital anomalies (including significant skeletal anomalies such as scoliosis, bony fusion involving the cervical vertebrae) not directly related to pectus excavatum;
  2. Bleeding disorders;
  3. Heart disease (including arrhythmia);
  4. Persons with active implantable medical devices (AIMD) such as pacemakers;
  5. Persons with a relative(s) or close family friend(s) living within their households and having a pacemaker;
  6. Persons with arteriovenous malformations;
  7. Chest deformity more complicated than pectus excavatum (e.g.. Poland syndrome);
  8. Persons for whom a foreign body implant would pose a risk (e.g., immunodeficiency);
  9. Persons at increased risk for general anesthesia (e.g., history of malignant hyperthermia);
  10. Respiratory conditions that have required steroid treatment (e.g., prednisone)in the last 3 years;
  11. Pregnancy;
  12. Inability to understand or follow instructions;
  13. Refusal to wear the external brace;
  14. Inability to obtain pre-approval (authorization) from the patient's insurance carrier; and
  15. Inability or refusal to return to UCSF for weekly follow-up visits for the first month after surgery.
  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: NCT00466206

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0570
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Michael R Harrison, MD University of California, San Francisco Medical Center and Children's Hospital
  More Information

Publications:

Responsible Party: Michael Harrison, Professor of Surgery and Pediatrics, Emeritus, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00466206     History of Changes
Other Study ID Numbers: FD 003341
Study First Received: April 24, 2007
Results First Received: May 11, 2012
Last Updated: August 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
pectus excavatum
magnetic alteration
chest wall deformity

Additional relevant MeSH terms:
Funnel Chest
Bone Diseases
Bone Diseases, Developmental
Congenital Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 28, 2014