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

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

NCT06172179•Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

"Retrospectively collecting clinical data from post-PVA (Percutaneous Vertebroplasty) patients, recording incidences of secondary vertebral fractures, and conducting statistical analysis to create a risk prediction model for recurrent fractures."

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Sun Yat-sen memorial hospital

Guangzhou, Guangdong, China

Key Dates

Start Date

December 1, 2023

Primary Completion Date

June 1, 2024

Completion Date

December 1, 2024

Last Updated

December 15, 2023

Enrollment

500

ESTIMATED participants

Conditions

Osteoporotic Vertebral FracturePrediction Model

Interventions

No interventions

OTHER

Contacts

Chunhai Li, MD

CONTACT

18602079796 lichhai@mail.sysu.edu.cn

hanwen cheng, Master

CONTACT

19541080926 chenghw3@mail2.sysu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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