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.
Study Type
OBSERVATIONAL
Enrollment
160
Clinica INO
Bogotá, Bogota D.C., Colombia
Satisfaction of body results
Body-QoL total score (0-100) from baseline to 6 months.
Time frame: 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)
Change in waist circumference (cm), reduction of the waist circumference
Time frame: 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
Safety Endpoint
spirometry values (FEV1, FVC, FEV1/FVC) from before surgery to 6 months after surgery
Time frame: 1 week before surgery and 6 months after surgery
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