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

Prediction Model Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172179
• Other study ID #: SYSKY-2023-1155-01
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Chunhai Li, MD
• Phone: 18602079796
• Email: lichhai[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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."

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Compression
• Osteoporotic Vertebral Fracture
• Spinal Fractures

Intervention

Other:
• No interventions
All procedures are observation. No intervention in this study.

Locations

Country	Name	City	State
China	Sun Yat-sen memorial hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	secondary vertebral fractures	Recording the secondary vertebral fractures	2 years post-operative