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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

NCT ID: NCT06172179

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-01

Brief Summary

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"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."

Detailed Description

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Conditions

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Osteoporotic Vertebral Fracture Prediction Model

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sun Yat-sen memorial hospital

No interventions

Intervention Type OTHER

All procedures are observation. No intervention in this study.

Second People's Hospital of Foshan City

No interventions

Intervention Type OTHER

All procedures are observation. No intervention in this study.

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

No interventions

Intervention Type OTHER

All procedures are observation. No intervention in this study.

Interventions

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No interventions

All procedures are observation. No intervention in this study.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chunhai Li, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Sun Yat-sen memorial hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunhai Li, MD

Role: CONTACT

Phone: 18602079796

Email: [email protected]

hanwen cheng, Master

Role: CONTACT

Phone: 19541080926

Email: [email protected]

Facility Contacts

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Chunhai Li, MD

Role: primary

hanwen cheng, Master

Role: backup

Other Identifiers

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SYSKY-2023-1155-01

Identifier Type: -

Identifier Source: org_study_id