Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures
Recruiting now · Not applicable
Conditions studied: Osteoporosis Fracture, Osteoporosis Vertebral, Compression Fracture, Perform PVP / PKP Treatment
In brief
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).
Key facts
- Study ID
- NCT06379243
- Run by
- The Seventh Affiliated Hospital of Sun Yat-sen University
- People needed
- 560
- Starts
- 2023-12-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2024-04-23
Who can join
Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
- The Seventh Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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