RecruitingNot ApplicableNCT06379243

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

Sponsor

The Seventh Affiliated Hospital of Sun Yat-sen University

Enrollment

560 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Compression Fracture Osteoporosis Fracture Osteoporosis Vertebral Perform PVP / PKP Treatment

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).

Eligibility

Min Age: 50 YearsMax Age: 90 Years

Inclusion Criteria3

Patients diagnosed with osteoporotic vertebral fractures of the thoracic and lumbar level with reference to the 2022 edition of the Osteoporotic Fractures Guidelines (2022 edition);
The presence of bone marrow edema or hemorrhage (acute fracture) in the fractured vertebrae is clearly defined by MR examination, and the responsible vertebrae is treated with PVP / PKP;
Number of fractured vertebrae: 1-3 vertebral compression fractures (including old fractures).

Exclusion Criteria3

History of severe scoliosis, vertebroplasty, or internal spinal fixation;
Presence of spinal infection and malignant neoplastic disease;
Presence of mental disease, cognitive impairment, or critical illness (e.g., severe cardiac or cerebrovascular disease).

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.