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NCT Number: NCT04452721

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

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.

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Key information

Conditions

Pectus Carinatum Bone Diseases Bone Diseases, Developmental Cartilage Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Skin and Connective Tissue Diseases

Age range

6 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Aurélien SCALABRE

CONTACT

[email protected]

0477829449

Aurélien SCALABRE

PRINCIPAL_INVESTIGATOR

About this study

The principal insvestigator hypothesizes 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

dynamic compression system

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélien SCALABRE

CONTACT

[email protected]

04 77 82 94 49

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: Pectusdyn

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 30, 2020
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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