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

The Seventh Affiliated Hospital of Sun Yat-sen University

Status

Enrolling

Conditions

Osteoporosis Vertebral

Osteoporosis Fracture

Compression Fracture

Perform PVP / PKP Treatment

Treatments

Procedure: PVP/PKP

Study type

Interventional

Funder types

Other

Identifiers

NCT06379243

KY-2023-008-02

Details and patient eligibility

About

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).

Enrollment

560 estimated patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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).