NCT07805941

Brief Summary

This prospective observational cohort will evaluate patient-reported and anthropometric outcomes after posterior aesthetic rib remodeling. Selected BODY-Q scales will measure body image, physical, psychological, sexual, and social function before surgery and through 12 months. Standardized waist and hip measurements will be collected at the same visits. The primary outcome is change in BODY-Q Body Image score at one year, and analyses will assess whether patient-reported improvement is associated with sustained waist reduction.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Feb 2024Dec 2026

Study Start

First participant enrolled

February 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

2.2 years

First QC Date

September 1, 2026

Last Update Submit

September 1, 2026

Conditions

Keywords

Rib RemodelingRIBOSSBODY-QBody ImageSexual FunctionPhysical FunctionPatient-Reported Outcomes

Outcome Measures

Primary Outcomes (1)

  • Change in BODY-Q Body Image Score

    Rasch-transformed 0-to-100 BODY-Q Body Image score; higher scores indicate a more positive body image. Change is the postoperative month-12 score minus baseline.

    Baseline and postoperative month 12. 1 year

Secondary Outcomes (4)

  • Change in BODY-Q Sexual Function Score

    Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year

  • Change in BODY-Q Physical, Psychological, and Social Function Scores

    Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year

  • Change in Waist Circumference

    Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year

  • Association Between Waist Reduction and BODY-Q Improvement

    Baseline and postoperative month 12. 1 year

Study Arms (1)

Posterior Rib Remodeling Cohort

Participants undergo the clinically selected posterior rib remodeling procedure and complete prospective BODY-Q and anthropometric assessments.

Procedure: Posterior Aesthetic Rib RemodelingOther: BODY-Q Assessment

Interventions

Posterior rib remodeling is performed according to the treating surgeon's standardized RIBOSS technique and clinical indications. The research protocol does not assign surgery; it observes outcomes after the independent treatment decision. Linked arm/group(s): Posterior Rib Remodeling Cohort.

Posterior Rib Remodeling Cohort

Selected licensed BODY-Q scales will be administered using the authorized Spanish translation and Rasch transformation. Proposed scales are Body Image, Physical Function, Psychological Function, Sexual Function, Social Function, and Body or Abdomen appearance satisfaction. Linked arm/group(s): Posterior Rib Remodeling Cohort.

Posterior Rib Remodeling Cohort

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults who independently elect posterior aesthetic rib remodeling and agree to longitudinal anthropometric and patient-reported outcome assessment.

You may qualify if:

  • Age 18 to 65 years.
  • Scheduled for posterior aesthetic rib remodeling after an independent clinical decision.
  • Ability to complete validated Spanish-language BODY-Q scales and follow-up visits.
  • Stable body weight for at least 3 months before surgery.
  • Written informed consent for prospective data collection.

You may not qualify if:

  • Prior posterior rib remodeling or rib resection.
  • Planned pregnancy during the 12-month follow-up.
  • Major weight-loss intervention planned during follow-up.
  • Psychiatric or cognitive condition preventing reliable completion of patient-reported measures.
  • Inability to complete baseline BODY-Q or standardized waist measurement.
  • Participation in another intervention expected to independently alter body image outcomes during follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica INO

Bogotá, Colombia

RECRUITING

Related Publications (4)

  • Manzaneda Cipriani RM, Duran Vega H, Cala Uribe L, Viaro M, Adrianzen GA, Botelho DL. Waist Remodeling without Incision, with Ultrasound-guided Monocortical Fracture. Plast Reconstr Surg Glob Open. 2023 Dec 19;11(12):e5499. doi: 10.1097/GOX.0000000000005499. eCollection 2023 Dec.

    PMID: 38115833BACKGROUND
  • Onate Valdivieso C, Onate Valdivieso D, Hoyos AE, Perez Pachon ME, Aguilar Villa H, Michels PJA, Viera A, Benavides JE, Villabona SJ, Ramirez B. Ultrasonic- and Ultrasound-assisted Improvement of Silhouette of the Torso: Bone Structure High-definition Remodeling (Part I). Plast Reconstr Surg Glob Open. 2024 Jan 10;12(1):e5513. doi: 10.1097/GOX.0000000000005513. eCollection 2024 Jan.

    PMID: 38204869BACKGROUND
  • Aguilar HA, Hoyos AE, Ramirez B, Kazbek K, Viacheslav N, Villabona SJ, Serrano HM, Perez Pachon ME, Valdivieso DO, Valdivieso CO, Kazbek G, Proto R, Verdugo JP, Varela A. Global Survey on Rib Remodeling Techniques: Assessing Complications and Safety in Waistline Contouring. Plast Reconstr Surg Glob Open. 2026 Apr 13;14(4):e7609. doi: 10.1097/GOX.0000000000007609. eCollection 2026 Apr.

    PMID: 41983160BACKGROUND
  • Aguilar Villa H, Villabona-Florez SJ, Hoyos AE, Perez Pachon ME, Serrano-Reyes HM, Diaz Sandoval CJ. Aesthetic Rib Cage Remodeling with Osteosynthesis: Body Structural High-Definition Reshaping (Rib Osteotomy with Osteosynthesis Stabilization). Plast Reconstr Surg. 2025 Feb 1;155(2):279-288. doi: 10.1097/PRS.0000000000011512. Epub 2024 May 6.

    PMID: 38710099BACKGROUND

Study Officials

  • Hugo Aguilar, MD, plastic surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo Aguilar, MD, Plastic surgeon

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 8, 2026

Study Start

February 1, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

NOT CONTEMPLED IN THE PATIENT INFORMED CONSENT

Locations