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

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.

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.

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.