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RECRUITING
NCT07813234

Prospective Evaluation of Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis for Lower Anterior Thoracic Prominence

Sponsor: Research Inc

View on ClinicalTrials.gov

Summary

This prospective single-group study will evaluate anterior aesthetic rib cage remodeling with osteosynthesis (ARCO) in adults with anteroinferior rib prominence or deformity. The procedure modifies and stabilizes ribs 6 through 8. Inferior rib cage perimeter, CT findings, spirometry, intraoperative respiratory variables, BODY-Q Chest scores, and complications will be assessed through 12 months. The primary outcomes are one-year perimeter change and major procedure-related complications.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

160

Start Date

2025-01-01

Completion Date

2026-12-01

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

PROCEDURE

Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis

Through small inframammary incisions, the lower borders of ribs 6, 7, and 8 are identified. The external cortical layer is cut using a piezoelectric device, controlled greenstick remodeling is performed, and each treated rib is stabilized with a contoured titanium plate and screws. The final surgical manual will specify treated ribs, target angle, fixation system, and verification steps. Linked arm/group(s): ARCO Procedure.

DIAGNOSTIC_TEST

Chest CT and Spirometry Follow-up

CT will assess rib angle, fixation, union, and thoracic complications. Spirometry will record FVC, FEV1, FEV1/FVC, peak expiratory flow, and FEF25-75 using standardized quality criteria. Linked arm/group(s): ARCO Procedure.

Locations (1)

Clinica INO

Bogotá, Colombia