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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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06172179
Enrollment
500
Registered
2023-12-15
Start date
2023-12-01
Completion date
2024-12-01
Last updated
2023-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporotic Vertebral Fracture, Prediction Model

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 risk prediction model for recurrent fractures.

Interventions

OTHERNo interventions

All procedures are observation. No intervention in this study.

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
secondary vertebral fractures2 years post-operativeRecording the secondary vertebral fractures

Countries

China

Contacts

Primary ContactChunhai Li, MD
lichhai@mail.sysu.edu.cn18602079796
Backup Contacthanwen cheng, Master
chenghw3@mail2.sysu.edu.cn19541080926

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026