Chest Wall DeformityNCT07813234
Prospective Evaluation of Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis for Lower Anterior Thoracic Prominence
An observational study of Chest Wall Deformity and Prominent Lower Rib Cage, run by Research Inc at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Wall Deformity, Prominent Lower Rib Cage
- What is being tested?
- Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis and Chest CT and Spirometry Follow-up
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2025to 1 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults seeking correction of anteroinferior rib cage prominence or deformity who meet the standardized ARCO operative criteria.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Clinica INO
Bogotá
hugo Aguilar, MD, Plastic surgeon, +57 301 6918526, havplasticacademy@gmail.com
About this study
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.
Read the 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.
- Conditions
- Chest Wall Deformity, Prominent Lower Rib Cage
- Being tested
- Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis, Chest CT and Spirometry Follow-up
- Keywords
- ARCO, Anterior Rib Remodeling, Osteosynthesis, Chest Wall Contouring, Spirometry, Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Aesthetic Rib Cage Remodeling With OsteosynthesisProcedure or 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-upDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| ARCO Procedure | Participants undergo anterior aesthetic rib cage remodeling with controlled greenstick rib modification and plate osteosynthesis, followed by standardized 12-month assessments. Receives: Procedure: Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis; Diagnostic Test: Chest CT and Spirometry Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and postoperative month 12. 12 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Jan 2025
- Primary completion1 May 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest Wall DeformityStudies of the same condition, open and under way.
- More trials run by Research IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugo Aguilar, MD, plastic surgery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813234
- Sponsor's protocol ID
- 012
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not contempled in the patient informed consent
Publications
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.
PubMed 41367927
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis for Lower Anterior Thoracic Prominence
- ClinicalTrials.gov ID
- NCT07813234
- Acronym / sponsor ID
- 012
- Conditions
- Chest Wall Deformity, Prominent Lower Rib Cage
- Keywords
- ARCO, Anterior Rib Remodeling, Osteosynthesis, Chest Wall Contouring, Spirometry, Computed Tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARCO Procedure | – | Procedure: Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis, Diagnostic Test: Chest CT and Spirometry Follow-upParticipants undergo anterior aesthetic rib cage remodeling with controlled greenstick rib modification and plate osteosynthesis, followed by standardized 12-month assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults seeking correction of anteroinferior rib cage prominence or deformity who meet the standardized ARCO operative criteria.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior Aesthetic Rib Cage Remodeling With OsteosynthesisThrough 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. | Procedure or surgery | ARCO Procedure |
| Chest CT and Spirometry Follow-upCT 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. | Diagnostic test | ARCO Procedure |
Primary outcome
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.
10 secondary outcomes
Incidence of Major ARCO-Related Complications
Time frame: From surgery through postoperative month 12. 12 months
Change in Spirometric Pulmonary Function FVC
Time frame: Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 months
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
Change in BODY-Q Chest Satisfaction Score
Time frame: Baseline, postoperative day 7, postoperative month 3, and postoperative month 12. 12 months
Change in Intraoperative Peak Inspiratory pressure
Time frame: Intraoperative: before rib remodeling, during remodeling, and after fixation during the index procedure. 1 day
Change in Intraoperative Pulmonary Compliance
Time frame: Intraoperative: before rib remodeling, during remodeling, and after fixation during the index procedure. 1 day
Change in Spirometric Pulmonary Function FEV1
Time frame: Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 months
Change in Spirometric Pulmonary Function FEV1/FVC
Time frame: Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 months
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 Spirometric Pulmonary Function FEF25-75
Time frame: Baseline, postoperative week 6, postoperative month 3, and postoperative month 12. 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 41367927Aguilar 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.
- Individual participant dataSharing planned: No. not contempled in the patient informed consent
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hugo Aguilar, MD, plastic surgery principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Wall Deformity and Prominent Lower Rib Cage, run by Research Inc at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hugo Aguilar, MD, Plastic surgeon (+57 301 6918526, havplasticacademy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inferior Rib Cage Perimeter at the Eighth-Rib Level (time frame: Baseline and postoperative month 12. 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07813234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.