Health TrialsbyHealthPanel

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

ConditionsChest Wall DeformityProminent Lower Rib Cage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorResearch Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis

    Procedure/Surgery

    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.

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: ARCO Procedure2 interventions

Trial outcomes

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.

Time frame
Baseline and postoperative month 12. 12 months

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Research Inc

Lead sponsor

Source ClinicalTrials.gov
Apply now