Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Dec 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how to predict the risk of new vertebral fractures in patients who have already experienced an osteoporotic vertebral compression fracture and have undergone a treatment called Percutaneous Vertebroplasty (PVA). The researchers are collecting medical information from patients to see how often these new fractures occur and to develop a model that can help identify patients who may be at higher risk for future fractures.

To be eligible for this study, patients need to be diagnosed with primary osteoporosis and have experienced a recent vertebral fracture in the lower back, confirmed by MRI. They should not have had any serious injuries, prior spinal surgeries (except for PVA), or certain other health conditions that could affect their participation. If you join the study, you will help researchers better understand how to prevent further fractures, which could lead to better care for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Meets the diagnostic criteria for primary osteoporosis as per the Osteoporosis Diagnosis and Treatment Guidelines (2022);
• • 2. No history of high-energy trauma;
• • 3. Patient complains of pain in the lumbar region, confirmed by MRI showing a newly developed vertebral fracture from T5 to L5 (i.e., MRI shows low signal on T1 and high or slightly high signal on T2);
• • 4. Has undergone Percutaneous Vertebroplasty (PVA) treatment.
• Exclusion Criteria:
• • 1. Incomplete imaging or medical record data;
• • 2. History of spinal surgeries other than PVA;
• • 3. Pre-existing symptoms of spinal cord compression or nerve root injury;
• • 4. Patients undergoing PVA treatment due to conditions such as tumors, vascular malformations, infections, or symptomatic Schmorl's nodes;
• • 5. Chronic conditions like Kummell's disease or non-union of old fractures;
• • 6. Concurrent vertebral burst fractures;
• • 7. Diagnosis of central nervous system diseases such as dementia or stroke before or during the follow-up period post-PVA procedure;
• • 8. History of violent trauma after PVA procedure.