Creating a model to predict re-fracture risk after spinal surgery for osteoporosis
Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures: a Multicenter Prospective Cohort Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 560 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | The Seventh Affiliated Hospital of Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06379243 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with 1-3 osteoporotic vertebral compression fractures who are undergoing PVP/PKP treatment.
Not a fit: Patients with a history of severe scoliosis, spinal infections, or critical illnesses may not benefit from this study.
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 performed: While similar approaches have been explored, this specific model for predicting re-fracture risk post-surgery is relatively novel.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.