Status:
UNKNOWN
Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Osteoporotic Vertebral Fracture
Prediction Model
Eligibility:
All Genders
18+ years
Brief Summary
"Retrospectively collecting clinical data from post-PVA (Percutaneous Vertebroplasty) patients, recording incidences of secondary vertebral fractures, and conducting statistical analysis to create a r...
Eligibility Criteria
Inclusion
- Meets the diagnostic criteria for primary osteoporosis as per the Osteoporosis Diagnosis and Treatment Guidelines (2022);
- No history of high-energy trauma;
- 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);
- Has undergone Percutaneous Vertebroplasty (PVA) treatment.
Exclusion
- Incomplete imaging or medical record data;
- History of spinal surgeries other than PVA;
- Pre-existing symptoms of spinal cord compression or nerve root injury;
- Patients undergoing PVA treatment due to conditions such as tumors, vascular malformations, infections, or symptomatic Schmorl's nodes;
- Chronic conditions like Kummell's disease or non-union of old fractures;
- Concurrent vertebral burst fractures;
- Diagnosis of central nervous system diseases such as dementia or stroke before or during the follow-up period post-PVA procedure;
- History of violent trauma after PVA procedure.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06172179
Start Date
December 1 2023
End Date
December 1 2024
Last Update
December 15 2023
Active Locations (1)
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1
Sun Yat-sen memorial hospital
Guangzhou, Guangdong, China, 510000