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

Sun Yat-sen University

Status: Enrolling

Conditions: Prediction Model; Osteoporotic Vertebral Fracture

Treatments: Other: No interventions

Study type: Observational

Funder types: Other

Identifiers

NCT06172179

SYSKY-2023-1155-01

Details and patient eligibility

About

"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."

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

500 participants in 3 patient groups

Sun Yat-sen memorial hospital

Treatment:

Other: No interventions

Second People's Hospital of Foshan City

Treatment:

Other: No interventions

The Fifth People's Hospital of Nanhai District, Foshan City

Treatment:

Other: No interventions