Creating a model to predict re-fracture risk after spinal surgery for osteoporosis
Official title: Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures: a Multicenter Prospective Cohort Study
Run by The Seventh Affiliated Hospital of Sun Yat-sen University · NCT06379243 · Data updated 2026-11-12
This study is trying to create a tool to help predict the risk of re-fractures in people with osteoporosis after they have spinal surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years to 90 Years |
| Sex | All |
| Enrollment | 560 (estimated) |
| Sponsor | The Seventh Affiliated Hospital of Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | April 23, 2024 |
| Trial ID | NCT06379243 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with 1-3 osteoporotic vertebral compression fractures who are undergoing PVP/PKP treatment.
✕Probably not a fit
Patients with a history of severe scoliosis, spinal infections, or critical illnesses may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project utilizes advanced imaging techniques to analyze the relationship between preoperative bone marrow fat content, magnetic properties of bone, and bone strength in patients with osteoporotic spinal fractures. The goal is to develop a personalized risk assessment model for vertebral re-fracture following PVP/PKP treatments. By combining clinical risk factors with quantitative MRI parameters, the study aims to provide an objective evaluation of re-fracture risk within the first year post-surgery.
Why it matters
Potential benefit: If successful, this model could significantly improve postoperative care by identifying patients at high risk for re-fracture, allowing for targeted interventions.
How similar studies have gone: While similar approaches have been explored, this specific model for predicting re-fracture risk post-surgery is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
The Seventh Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: qingyu liu — The Seventh Affiliated Hospital of Sun Yat-sen University
- Study coordinator: jinhui cai
- Email: caijinhui123456@163.com
- Phone: +86 18002299663
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.