Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures
Recruiting · NCT06379243 · Interventional (participants receive a specific treatment) · Lead sponsor: The Seventh Affiliated Hospital of Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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).
Who can take part
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).
Where it is running
1 location listed.
- The Seventh Affiliated Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China