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

Research Inc160 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Chest Wall Deformity Prominent Lower Rib Cage

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline and postoperative month 12. 12 months

Secondary Outcomes

Incidence of Major ARCO-Related Complications

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.

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

Change in Spirometric Pulmonary Function FVC

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

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

CT-Confirmed Structural Stability

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.

Time frame: 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

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

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

Change in Intraoperative Peak Inspiratory pressure

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

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

Change in Intraoperative Pulmonary Compliance

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

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

Change in Spirometric Pulmonary Function FEV1

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

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

Change in Spirometric Pulmonary Function FEV1/FVC

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

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

Change in Spirometric Pulmonary Function peak expiratory flow

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

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

Change in Spirometric Pulmonary Function FEF25-75

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts