About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Single group
Treatments tested in this trial
PVP/PKP
Procedure/SurgeryPVP or PKP surgery in patients with osteoporotic vertebral compression fractures
Treatment groups
Trial outcomes
Primary outcomes
Non-operative vertebral re-fracture within 1 year after PVP / PKP
Non-operative vertebral re-fracture within 1 year after PVP / PKP, confirmed by follow-up spinal MRI
Secondary outcomes
Visual Analog Score (VAS) at 1 year after PVP/ PKP
Visual Analog Score (VAS) at 1 year after PVP / PKP were obtained by completing the appropriate questionnaires on-site at the time of the 1-year postoperative spinal MRI review.
Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP
Oswestry Dysfunction Index (ODI) at 1 year after PVP / PKP were obtained by completing the appropriate questionnaires on-site at the time of the 1-year postoperative spinal MRI review.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Seventh Affiliated Hospital of Sun Yat-sen University
Lead sponsor
Guangzhou Medical University
Collaborator
Huizhou Municipal Central Hospital
Collaborator
Dongguan Hospital of Traditional Chinese Medicine
Collaborator