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

University of Sao Paulo60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pectus Carinatum, Chondromanubrial

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Hospital de Clinicas da Faculdade de Botucatu

Botucatu, São Paulo, Brazil

RECRUITING

Hospital das Clinicas da Unicamp

Campinas, São Paulo, Brazil

RECRUITING

Instituto do Coracao (InCor) HCFMUSP

São Paulo, São Paulo, Brazil

RECRUITING

Hospital das Clinicas da USP Ribeirao

Ribeirão Preto, Brazil

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 16 months

Secondary Outcomes

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

Time frame: 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.

Time frame: 16 months