RIBOSS-01: Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing

Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07705295

Acronym

(RIBOSS)

Enrollment

160

Registered

2026-07-15

Start date

2026-02-20

Completion date

2027-02-20

Last updated

2026-07-15

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

Conditions

Body Contouring Surgery

Keywords

rib remodelation surgery, hip

Brief summary

The goal of this observational study is to learn about the long-term effects of RIBOSS intervention and demonstrate non-inferiority of postoperative respiratory function (FEV1, FVC, FEV1/FVC) at 6 months in the RIBOSS group compared with controls, using a non-inferiority margin of ≤0.10 L for FEV1 and FVC, and ≤0.05 for the ratio.

Detailed description

Secondary Objectives: * To quantify hip circumference, change and waist-hip ratio improvement. * To compare intraoperative and postoperative pain levels (VAS) up to 1 month. * To assess radiological consolidation and plate angulation at 3 and 6 months. * To record early and late complications (Clavien-Dindo classification) up to 12 months. * To measure time to return to physical activity and overall satisfaction.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Candidates for elective waist narrowing through high-definition liposculpture. * Rib XI-XII projection ≥7 cm (CT-based). * Baseline spirometry within predicted limits. * Ability to provide informed consent and complete Body-QoL questionnaire.

Exclusion criteria

* Prior thoracic surgery, trauma, or rib agenesis. * Osteoporosis or bone metabolic disease. * Chronic pulmonary or systemic disease. * Coagulopathy or psychiatric disorder limiting adherence. * Pregnancy or lactation. * Allergy to titanium implants.

Design outcomes

Primary

Measure	Time frame	Description
Satisfaction of body results	1 day before surgery, 1 day after surgery, 7 days after surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery	Body-QoL total score (0-100) from baseline to 6 months.
Change in waist circumference (cm)	1 day before surgery, 1 day after surgery, 7 days after surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery	Change in waist circumference (cm), reduction of the waist circumference

Secondary

Measure	Time frame	Description
Safety Endpoint	1 week before surgery and 6 months after surgery	spirometry values (FEV1, FVC, FEV1/FVC) from before surgery to 6 months after surgery

Countries

Colombia

Contacts

PRINCIPAL_INVESTIGATORHugo Aguilar, MD, plastic surgery

HAV Academy

STUDY_DIRECTORBrian Ramirez, MD, Aerospace medicine, MSc, P

Research Inc

Outcome results