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Pectus carinatum (PC) is a congenital deformity of the chest wall whose prevalence is 0.6% of the population and although it does not cause cardio respiratory physiological damage, it has profound psychological effects on young people. Its treatment today is still primarily surgical in our country, despite the fact that conservative treatment by chest compression may be effective in the chondrogladiolar variant, which represents 90% of cases of PC. The aim of the present study is to conservatively treat a series of 60 patients using a new modular and adjustable chest compressor model to assess the effectiveness of this chest compressor in the noninvasive treatment of PC; and also assess the safety of such treatment by the rate of adverse events occurring during treatment. Secondary objectives will be to evaluate the adherence that PC patients have to this type of treatment by quantifying the number of hours of use per day, besides evaluating the chest compressor and its components for durability and resistance as a device for continuous use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bracing arm | Other | Patients that will be using the thoracic compressor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic compressor | Device | The intervention is the use of the thoracic compressor for the conservative treatment of pectus carinatum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficiency in repairing the pectus carinatum | The anthroprometric measures in centimeters of the thoracic cage will be taken before and after the treatment to evaluate the effectiveness of the chest compressor in repairing the pectus carinatum | 16 months |
| Treatment safety | The adverse events that can possibly occur during treatment will be recorded in the patients using the chest compressor for pectus carinatum repair | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment adherence | The number of hours of daily use of the chest compressor will be recorded as a measurement of the level of adherence to the chest compressor treatment | 16 months |
| Device durability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Tedde, MD, PhD | Instituto do Coracao (InCor) HCFMUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas da Faculdade de Botucatu | Recruiting | Botucatu | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16080931 | Result | Kelly RE Jr, Lawson ML, Paidas CN, Hruban RH. Pectus excavatum in a 112-year autopsy series: anatomic findings and the effect on survival. J Pediatr Surg. 2005 Aug;40(8):1275-8. doi: 10.1016/j.jpedsurg.2005.05.010. | |
| 8641129 | Result | 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. |
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| ID | Term |
|---|---|
| D066166 | Pectus Carinatum |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D002357 | Cartilage Diseases |
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Patients will be allocated to use the thoracic compressor for 16 months
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The mechanic problems presented by the chest compressor as fractures, screw loosening or fastener break will be recorded as a durability and strength measure of the chest compressor and its components.
| 16 months |
| Hospital das Clinicas da Unicamp | Recruiting | Campinas | São Paulo | Brazil |
|
| Instituto do Coracao (InCor) HCFMUSP | Recruiting | São Paulo | São Paulo | Brazil |
|
| Hospital das Clinicas da USP Ribeirao | Recruiting | Ribeirão Preto | Brazil |
|
| 17660066 | Result | Kelly RE Jr, Shamberger RC, Mellins RB, Mitchell KK, Lawson ML, Oldham K, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Bagley TC, Moskowitz AB. Prospective multicenter study of surgical correction of pectus excavatum: design, perioperative complications, pain, and baseline pulmonary function facilitated by internet-based data collection. J Am Coll Surg. 2007 Aug;205(2):205-16. doi: 10.1016/j.jamcollsurg.2007.03.027. Epub 2007 Jun 21. |
| 23657247 | Result | Desmarais TJ, Keller MS. Pectus carinatum. Curr Opin Pediatr. 2013 Jun;25(3):375-81. doi: 10.1097/MOP.0b013e3283604088. |
| D009139 |
| Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |