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

NCT07813234 | Recruiting

• 1 other identifier: 012
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chest Wall Deformity; Prominent Lower Rib Cage

Keywords

ARCO; Anterior Rib Remodeling; Osteosynthesis; Chest Wall Contouring; Spirometry; Computed Tomography

Outcome Measures

Primary Outcomes (1)

• Change in Inferior Rib Cage Perimeter at the Eighth-Rib Level

  Circumference in centimeters will be measured using a standardized horizontal landmark at end-expiration. Three measurements will be averaged. Change is the 12-month value minus baseline; a negative value indicates perimeter reduction.

  Baseline and postoperative month 12. 12 months

Secondary Outcomes (10)

• Incidence of Major ARCO-Related Complications

  From surgery through postoperative month 12. 12 months

• Change in Spirometric Pulmonary Function FVC

  Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 months

• CT-Confirmed Structural Stability

  Postoperative week 6, postoperative month 3, and postoperative month 12 if the final radiation protocol includes the 12-month CT. 12 months

• Change in BODY-Q Chest Satisfaction Score

  Baseline, postoperative day 7, postoperative month 3, and postoperative month 12. 12 months

• Change in Intraoperative Peak Inspiratory pressure

  Intraoperative: before rib remodeling, during remodeling, and after fixation during the index procedure. 1 day

Study Arms (1)

ARCO Procedure

Participants undergo anterior aesthetic rib cage remodeling with controlled greenstick rib modification and plate osteosynthesis, followed by standardized 12-month assessments.

Procedure: Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis; Diagnostic Test: Chest CT and Spirometry Follow-up

Interventions

Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis PROCEDURE

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.

ARCO Procedure

Chest CT and Spirometry Follow-up DIAGNOSTIC_TEST

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.

ARCO Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults seeking correction of anteroinferior rib cage prominence or deformity who meet the standardized ARCO operative criteria.

You may qualify if:

• Age 18 to 45 years, or older participants with documented acceptable bone health under the final protocol.
• Prominence, dysmorphia, or contour concern involving the anteroinferior rib cage and judged appropriate for ARCO.
• Preoperative chest CT, spirometry, medical history, and physical examination completed.
• BMI 30 kg/m2 or lower.
• Ability to comply with CT, spirometry, BODY-Q, and clinical follow-up through 12 months.
• Written informed consent

You may not qualify if:

• Osteoarticular disease affecting rib integrity or clinically relevant osteoporosis risk.
• Previous major chest surgery or significant thoracic trauma.
• Coagulation disorder, chronic pulmonary disease, or uncontrolled systemic disease.
• Active cancer, short life expectancy, or contraindication to elective surgery.
• Known adverse reaction to the proposed osteosynthesis material.
• Psychiatric condition or body-image disorder that, after specialist assessment when indicated, impairs informed decision-making or realistic expectations.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

Clinica INO

Bogotá, Colombia

RECRUITING

Related Publications (1)

• Aguilar Villa H, Ramirez B, Villabona-Florez SJ, Hoyos AE, Perez Pachon ME, Serrano-Reyes HM, Valdivieso CO, Valdivieso DO, Barajas-Gamboa J, Varela A, Proto R, Diaz CJ. Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis. Plast Reconstr Surg Glob Open. 2025 Dec 8;13(12):e7109. doi: 10.1097/GOX.0000000000007109. eCollection 2025 Dec.

  PMID: 41367927 BACKGROUND

MeSH Terms

Interventions

Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Hugo Aguilar, MD, plastic surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo Aguilar, MD, Plastic surgeon

CONTACT

+57 301 6918526; havplasticacademy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 10, 2026
• Study Start: January 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)