Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07813234

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chest Wall Deformity Prominent Lower Rib Cage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Participants who meet standardized ARCO eligibility criteria will undergo preoperative chest CT, spirometry, anthropometry, photography, and BODY-Q assessment. During surgery, controlled greenstick remodeling of the selected anterior ribs will be followed by plate osteosynthesis. Peak inspiratory pressure and pulmonary compliance will be recorded before remodeling, during the maneuver, and after fixation, and thoracic ultrasound will assess pleural integrity. Postoperative CT will evaluate angulation, union, and hardware position; spirometry will assess pulmonary function; and standardized perimeter and BODY-Q measurements will assess aesthetic effectiveness. Complications will be actively collected through month 12.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Inferior Rib Cage Perimeter at the Eighth-Rib Level

    Time frame: Baseline and postoperative month 12. 12 months

    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.

Secondary outcomes

  1. Incidence of Major ARCO-Related Complications

    Time frame: From surgery through postoperative month 12. 12 months

    Proportion of participants with pneumothorax requiring drainage, hemothorax, fixation failure requiring intervention, symptomatic nonunion/malunion, deep infection, respiratory deterioration requiring treatment, unplanned reoperation, or another serious procedure-related event.

  2. Change in Spirometric Pulmonary Function FVC

    Time frame: Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 months

    Change in FVC from baseline. Values will be reported in liters, ratios, and percent predicted as appropriate.

  3. CT-Confirmed Structural Stability

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

    Proportion of treated ribs with maintained planned angulation, stable plate and screw position, evidence of union, and no clinically significant loss of correction, nonunion, malunion, or hardware migration.

  4. Change in BODY-Q Chest Satisfaction Score

    Time frame: Baseline, postoperative day 7, postoperative month 3, and postoperative month 12. 12 months

    Rasch-transformed 0-to-100 BODY-Q Chest score; higher values indicate greater satisfaction with chest appearance.

  5. Change in Intraoperative Peak Inspiratory pressure

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

    Peak inspiratory pressure will be recorded at standardized ventilator settings immediately before rib remodeling, during open greenstick modification, and after definitive fixation.

  6. Change in Intraoperative Pulmonary Compliance

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

    dynamic pulmonary compliance will be recorded at standardized ventilator settings immediately before rib remodeling, during open greenstick modification, and after definitive fixation.

  7. Change in Spirometric Pulmonary Function FEV1

    Time frame: Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 months

    Change in FEV1from baseline. Values will be reported in liters, ratios, and percent predicted as appropriate.

  8. Change in Spirometric Pulmonary Function FEV1/FVC

    Time frame: Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 months

    Change in FEV1/FVC from baseline. Values will be reported in liters, ratios, and percent predicted as appropriate.

  9. Change in Spirometric Pulmonary Function peak expiratory flow

    Time frame: Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 months

    Change in peak expiratory flow from baseline. Values will be reported in liters, ratios, and percent predicted as appropriate.

  10. Change in Spirometric Pulmonary Function FEF25-75

    Time frame: Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 months

    Change in FEF25-75 from baseline. Values will be reported in liters, ratios, and percent predicted as appropriate.

Study contacts

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

Hugo Aguilar, MD, Plastic surgeon

CONTACT

[email protected]

+57 301 6918526

Sponsors and collaborators

Lead sponsor

Research Inc

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.