Magnetic Mini-Mover Procedure to Treat Pectus Excavatum

NCT00466206 | Completed Phase 1 Results DMC

• 1 other identifier: FD 003341
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Excavatum

Keywords

pectus excavatum; magnetic alteration; chest wall deformity

Outcome Measures

Primary Outcomes (4)

• Affect on Cardiac Activity

  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.

  One month post-explantation

• Damage/Discoloration to Skin

  Outcome measure is number of patients who experienced permanent skin damage or discoloration due to external brace wear

  One-month post-explant

• Efficacy: Patient Satisfaction

  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

  One year post-explant

• Efficacy: Patient Recommendation of Treatment

  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

  One year post-explanation

Secondary Outcomes (1)

• Patient Compliance

  18 months active Rx

Study Arms (1)

3MP - Treatment Arm

EXPERIMENTAL

Magnetic Mini-Mover Procedure using the Magnimplant and Magnatract

Device: Magnetic Mini-Mover Procedure (3MP); Device: Magnatract (external magnet in a removable external brace); Procedure: 3MP (Magnetic Mini-Mover Procedure)

Interventions

Magnetic Mini-Mover Procedure (3MP) DEVICE

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.

Also known as: 3MP

3MP - Treatment Arm

Magnatract (external magnet in a removable external brace) DEVICE

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.

Also known as: Magnetic Mini-mover

3MP - Treatment Arm

3MP (Magnetic Mini-Mover Procedure) 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.

Also known as: 3MP

3MP - Treatment Arm

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• FDA Office of Orphan Products Development: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143-0570, United States

Location

Related Publications (19)

• RAVITCH MM. The operative treatment of pectus excavatum. J Pediatr. 1956 Apr;48(4):465-72. doi: 10.1016/s0022-3476(56)80075-9. No abstract available.

  PMID: 13295996 BACKGROUND

• WELCH KJ. Satisfactory surgical correction of pectus excavatum deformity in childhood; a limited opportunity. J Thorac Surg. 1958 Nov;36(5):697-713. No abstract available.

  PMID: 13588724 BACKGROUND

• Morshuis WJ, Mulder H, Wapperom G, Folgering HT, Assman M, Cox AL, van Lier HJ, Vincent JG, Lacquet LK. Pectus excavatum. A clinical study with long-term postoperative follow-up. Eur J Cardiothorac Surg. 1992;6(6):318-28; discussion 328-9. doi: 10.1016/1010-7940(92)90149-r.

  PMID: 1616728 BACKGROUND

• ADKINS PC, BLADES B. A stainless steel strut for correction of pectus escavatum. Surg Gynecol Obstet. 1961 Jul;113:111-3. No abstract available.

  PMID: 13681493 BACKGROUND

• Shamberger RC. Congenital chest wall deformities. Curr Probl Surg. 1996 Jun;33(6):469-542. doi: 10.1016/s0011-3840(96)80005-0. No abstract available.

  PMID: 8641129 BACKGROUND

• Nuss D, Croitoru DP, Kelly RE Jr, Goretsky MJ, Nuss KJ, Gustin TS. Review and discussion of the complications of minimally invasive pectus excavatum repair. Eur J Pediatr Surg. 2002 Aug;12(4):230-4. doi: 10.1055/s-2002-34485.

  PMID: 12368998 BACKGROUND

• Beiser GD, Epstein SE, Stampfer M, Goldstein RE, Noland SP, Levitsky S. Impairment of cardiac function in patients with pectus excavatum, with improvement after operative correction. N Engl J Med. 1972 Aug 10;287(6):267-72. doi: 10.1056/NEJM197208102870602. No abstract available.

  PMID: 5038952 BACKGROUND

• Lawson ML, Cash TF, Akers R, Vasser E, Burke B, Tabangin M, Welch C, Croitoru DP, Goretsky MJ, Nuss D, Kelly RE Jr. A pilot study of the impact of surgical repair on disease-specific quality of life among patients with pectus excavatum. J Pediatr Surg. 2003 Jun;38(6):916-8. doi: 10.1016/s0022-3468(03)00123-4.

  PMID: 12778393 BACKGROUND

• Wynn SR, Driscoll DJ, Ostrom NK, Staats BA, O'Connell EJ, Mottram CD, Telander RL. Exercise cardiorespiratory function in adolescents with pectus excavatum. Observations before and after operation. J Thorac Cardiovasc Surg. 1990 Jan;99(1):41-7.

  PMID: 2294364 BACKGROUND

• Haller JA Jr, Loughlin GM. Cardiorespiratory function is significantly improved following corrective surgery for severe pectus excavatum. Proposed treatment guidelines. J Cardiovasc Surg (Torino). 2000 Feb;41(1):125-30.

  PMID: 10836238 BACKGROUND

• Zhao L, Feinberg MS, Gaides M, Ben-Dov I. Why is exercise capacity reduced in subjects with pectus excavatum? J Pediatr. 2000 Feb;136(2):163-7. doi: 10.1016/s0022-3476(00)70096-5.

  PMID: 10657820 BACKGROUND

• Mead J, Sly P, Le Souef P, Hibbert M, Phelan P. Rib cage mobility in pectus excavatum. Am Rev Respir Dis. 1985 Dec;132(6):1223-8. doi: 10.1164/arrd.1985.132.6.1223.

  PMID: 4073662 BACKGROUND

• Shamberger RC. Cardiopulmonary effects of anterior chest wall deformities. Chest Surg Clin N Am. 2000 May;10(2):245-52, v-vi.

  PMID: 10803331 BACKGROUND

• Malek MH, Fonkalsrud EW, Cooper CB. Ventilatory and cardiovascular responses to exercise in patients with pectus excavatum. Chest. 2003 Sep;124(3):870-82. doi: 10.1378/chest.124.3.870.

  PMID: 12970011 BACKGROUND

• Hebra A, Swoveland B, Egbert M, Tagge EP, Georgeson K, Othersen HB Jr, Nuss D. Outcome analysis of minimally invasive repair of pectus excavatum: review of 251 cases. J Pediatr Surg. 2000 Feb;35(2):252-7; discussion 257-8. doi: 10.1016/s0022-3468(00)90019-8.

  PMID: 10693675 BACKGROUND

• Park HJ, Lee SY, Lee CS. Complications associated with the Nuss procedure: analysis of risk factors and suggested measures for prevention of complications. J Pediatr Surg. 2004 Mar;39(3):391-5; discussion 391-5. doi: 10.1016/j.jpedsurg.2003.11.012.

  PMID: 15017558 BACKGROUND

• Weber TR. Further experience with the operative management of asphyxiating thoracic dystrophy after pectus repair. J Pediatr Surg. 2005 Jan;40(1):170-3. doi: 10.1016/j.jpedsurg.2004.09.039.

  PMID: 15868580 BACKGROUND

• Fonkalsrud EW, Reemtsen B. Force required to elevate the sternum of pectus excavatum patients. J Am Coll Surg. 2002 Oct;195(4):575-7. doi: 10.1016/s1072-7515(02)01245-0. No abstract available.

  PMID: 12375767 BACKGROUND

• Kowalewski J, Barcikowski S, Brocki M. Cardiorespiratory function before and after operation for pectus excavatum: medium-term results. Eur J Cardiothorac Surg. 1998 Mar;13(3):275-9. doi: 10.1016/s1010-7940(97)00326-6.

  PMID: 9628377 RESULT

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Technical problems with measurement of PSI. PSI is uninformative in assessing efficacy of treatment as it is a dynamic measure that varies with patient position and respiration at any given measurement.

Results Point of Contact

• Title: Michael Harrison, MD
• Organization: UCSF-Benioff Children's Hospital

pedsurg@ucsfmedctr.org

415 476-2538

Study Officials

• Michael R Harrison, MD

  University of California, San Francisco Medical Center and Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery and Pediatrics, Emeritus

Study Record Dates

• First Submitted: April 24, 2007
• First Posted: April 27, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: April 1, 2011
• Last Updated: January 1, 2016
• Results First Posted: September 3, 2012

Record last verified: 2015-12

Locations

US (1)