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

Recruiting

• Conditions: Pectus Carinatum
• Interventions: Other: dynamic compression system

• Registration Number: NCT04452721
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-06-30
• Study Start: 2020-07-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 520

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective cohort	dynamic compression system	340 to 400 patients
Validation cohort	dynamic compression system	120 patients

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	After the end of treatment (6 months to 2 years)	Dynamic compression system

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France