NCT06379243

Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures

Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures: a Multicenter Prospective Cohort Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: The Seventh Affiliated Hospital of Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

In this project, IDEAL-IQ technology and PDFF and R2\* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after PVP / PKP, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after PVP / PKP. To construct a precise and individualized risk assessment model of vertebral re-fracture after PVP/ PKP by combining clinical risk factors, preoperative quantitative MRI parameters (PDFF, R2\*) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year).

Conditions

• Osteoporosis Fracture
• Osteoporosis Vertebral
• Compression Fracture
• Perform PVP / PKP Treatment

Interventions

Type	Name	Description
PROCEDURE	PVP/PKP	PVP or PKP surgery in patients with osteoporotic vertebral compression fractures

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-04-23
• Last updated: 2024-04-23

Locations

1 site across 1 country: China