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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07813234
Enrollment
160
Registered
2026-09-10
Start date
2025-01-01
Completion date
2026-12-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Wall Deformity, Prominent Lower Rib Cage

Keywords

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

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.

Detailed description

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.

Interventions

PROCEDUREAnterior 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_TESTChest 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.

Sponsors

Research Inc
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Inferior Rib Cage Perimeter at the Eighth-Rib LevelBaseline and postoperative month 12. 12 monthsCircumference 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

MeasureTime frameDescription
Incidence of Major ARCO-Related ComplicationsFrom surgery through postoperative month 12. 12 monthsProportion 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.
Change in Spirometric Pulmonary Function FVCBaseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 monthsChange in FVC from baseline. Values will be reported in liters, ratios, and percent predicted as appropriate.
CT-Confirmed Structural StabilityPostoperative week 6, postoperative month 3, and postoperative month 12 if the final radiation protocol includes the 12-month CT. 12 monthsProportion 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.
Change in BODY-Q Chest Satisfaction ScoreBaseline, postoperative day 7, postoperative month 3, and postoperative month 12. 12 monthsRasch-transformed 0-to-100 BODY-Q Chest score; higher values indicate greater satisfaction with chest appearance.
Change in Intraoperative Peak Inspiratory pressureIntraoperative: before rib remodeling, during remodeling, and after fixation during the index procedure. 1 dayPeak inspiratory pressure will be recorded at standardized ventilator settings immediately before rib remodeling, during open greenstick modification, and after definitive fixation.
Change in Intraoperative Pulmonary ComplianceIntraoperative: before rib remodeling, during remodeling, and after fixation during the index procedure. 1 daydynamic pulmonary compliance will be recorded at standardized ventilator settings immediately before rib remodeling, during open greenstick modification, and after definitive fixation.
Change in Spirometric Pulmonary Function FEV1Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 monthsChange in FEV1from baseline. Values will be reported in liters, ratios, and percent predicted as appropriate.
Change in Spirometric Pulmonary Function FEV1/FVCBaseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 monthsChange in FEV1/FVC from baseline. Values will be reported in liters, ratios, and percent predicted as appropriate.
Change in Spirometric Pulmonary Function peak expiratory flowBaseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 monthsChange in peak expiratory flow from baseline. Values will be reported in liters, ratios, and percent predicted as appropriate.
Change in Spirometric Pulmonary Function FEF25-75Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 monthsChange in FEF25-75 from baseline. Values will be reported in liters, ratios, and percent predicted as appropriate.

Countries

Colombia

Contacts

CONTACTHugo Aguilar, MD, Plastic surgeon
havplasticacademy@gmail.com+57 301 6918526
PRINCIPAL_INVESTIGATORHugo Aguilar, MD, plastic surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026