Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System

Overview

Pectus carinatum is a deformation of the thoracic wall causing an aesthetic prejudice. Since 2011, our team uses a dynamic compression system to treat this deformation. It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it. The local cohort is one of the largest in the world. The few previous publications have shown the validity of this method, but the prognosis factors for success of this innovative treatment are not yet identified.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: December 2020

Detailed Description

We hypothesize that the success or failure of the treatment depends on several parameters assessable before treatment, such as the patient's age, gender, initial correction pressure, symmetry or not of the deformation.

Interventions

  • Other: dynamic compression system
    • It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it

Arms, Groups and Cohorts

  • Retrospective cohort
    • 340 to 400 patients
  • Validation cohort
    • 120 patients

Clinical Trial Outcome Measures

Primary Measures

  • Decrease of the deformation of more than 50% (measured in mm) after 6 months of treatment
    • Time Frame: After 6 months of treatment
    • Dynamic compression system

Secondary Measures

  • Failure of treatment assessed by the patient, ie if the patients considers the treatment to have failed, if he choose to underwent surgery afterwards, or if he considered the pectus carinatum to have relapsed
    • Time Frame: After the end of treatment (6 months to 2 years)
    • Dynamic compression system

Participating in This Clinical Trial

Inclusion Criteria

  • Patient who received proper information about the study.
  • Patient with clinically diagnosed pectus carinatum.
  • Treated at Saint-Etienne University Hospital using a dynamic compression system.
  • Between October 2011 and January 2020 for the retrospective part, then between January 2020 and January 2022 for the validation cohort.
  • With more than 6 months of follow-up since the beginning of the treatment.

Exclusion Criteria

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Saint Etienne
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • AurĂ©lien SCALABRE, Principal Investigator, CHU Saint-Etienne
  • Overall Contact(s)
    • AurĂ©lien SCALABRE, 04 77 82 94 49, aurelien.scalabre@chu-etienne.fr

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