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

NCT06172179 | Unknown DMC

• 1 other identifier: SYSKY-2023-1155-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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."

Conditions

Osteoporotic Vertebral Fracture; Prediction Model

Outcome Measures

Primary Outcomes (1)

• secondary vertebral fractures

  Recording the secondary vertebral fractures

  2 years post-operative

Study Arms (3)

Sun Yat-sen memorial hospital

Other: No interventions

Second People's Hospital of Foshan City

Other: No interventions

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

Other: No interventions

Interventions

No interventions OTHER

All procedures are observation. No intervention in this study.

Second People's Hospital of Foshan City; Sun Yat-sen memorial hospital; The Fifth People's Hospital of Nanhai District, Foshan City

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older population with osteoporosis, who have undergone vertebral augmentation procedures due to osteoporotic vertebral fractures.

You may qualify if:

• Meets the diagnostic criteria for primary osteoporosis as per the Osteoporosis Diagnosis and Treatment Guidelines (2022);
• No history of high-energy trauma;
• 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);
• Has undergone Percutaneous Vertebroplasty (PVA) treatment.

You may not qualify if:

• Incomplete imaging or medical record data;
• History of spinal surgeries other than PVA;
• Pre-existing symptoms of spinal cord compression or nerve root injury;
• Patients undergoing PVA treatment due to conditions such as tumors, vascular malformations, infections, or symptomatic Schmorl's nodes;
• Chronic conditions like Kummell's disease or non-union of old fractures;
• Concurrent vertebral burst fractures;
• Diagnosis of central nervous system diseases such as dementia or stroke before or during the follow-up period post-PVA procedure;
• History of violent trauma after PVA procedure.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen memorial hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Study Officials

• Chunhai Li, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunhai Li, MD

CONTACT

18602079796; lichhai@mail.sysu.edu.cn

hanwen cheng, Master

CONTACT

19541080926; chenghw3@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)