Chest Compressor for Conservative Treatment of Pectus Carinatum: a Multicenter Study

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of a Modular and Adjustable Chest Compressor Model for Conservative Treatment of Pectus Carinatum: a Multicenter Study

Conditions
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Pectus Carinatum, Chondromanubrial

Intervention / Treatment
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* Device: Thoracic compressor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pectus carinatum condrogladiolar Variant No other comorbidities that could interfere with the use of compressor Exclusion Criteria: Marfan Syndrome Active cardiovascular disease Significant scoliosis or thoracic deformity Important obesity Pectus carinatum chondromanubrial variant Poor commitment to protocol by both research participant and parents

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients will be allocated to use the thoracic compressor for 16 months
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bracing arm<br>Patients that will be using the thoracic compressor | Device: Thoracic compressor<br>* The intervention is the use of the thoracic compressor for the conservative treatment of pectus carinatum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Braces, Conservative treatment, Thoracic wall, Pectus carinatum