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

NCT04452721 | Recruiting

• 1 other identifier: 20CH030
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Carinatum

Keywords

Pectus Carinatum; Dynamic compression system

Outcome Measures

Primary Outcomes (1)

• Decrease of the deformation of more than 50% (measured in mm) after 6 months of treatment

  Dynamic compression system

  After 6 months of treatment

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

  After the end of treatment (6 months to 2 years)

Study Arms (2)

Retrospective cohort

340 to 400 patients

Other: dynamic compression system

Validation cohort

120 patients

Other: dynamic compression system

Interventions

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

Retrospective cohort; Validation cohort

Eligibility Criteria

• Age: 6 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Refusal to participate to this treatment

You may qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

Related Publications (1)

• Kieffer De Marco L, Filaire L, Vermersch S, Chapelle C, Garcin A, Tiffet O, Scalabre A. Prognostic Factors for Pectus Carinatum Treated by Dynamic Compression System: PECTUSDYN Trial. Eur J Cardiothorac Surg. 2026 Jan 6;68(1):ezaf444. doi: 10.1093/ejcts/ezaf444.

  PMID: 41390917 DERIVED

MeSH Terms

Conditions

Pectus Carinatum

Condition Hierarchy (Ancestors)

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

Study Officials

• Aurélien SCALABRE

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélien SCALABRE

CONTACT

04 77 82 94 49; aurelien.scalabre@chu-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: June 30, 2020
• Study Start: July 7, 2020
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)