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

"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."

Study Overview

• Status: Recruiting
• Conditions: Prediction Model; Osteoporotic Vertebral Fracture
• Intervention / Treatment: Other: No interventions

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Chunhai Li, MD; Phone Number: 18602079796; Email: lichhai@mail.sysu.edu.cn
• Study Contact Backup: Name: hanwen cheng, Master; Phone Number: 19541080926; Email: chenghw3@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen Memorial Hospital
      • Contact: Chunhai Li, MD; Phone Number: 18602079796; Email: lichhai@mail.sysu.edu.cn
      • Contact: hanwen cheng, Master; Phone Number: 19541080926; Email: chenghw3@mail2.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sun Yat-sen memorial hospital	Other: No interventions; All procedures are observation. No intervention in this study.
Second People's Hospital of Foshan City	Other: No interventions; All procedures are observation. No intervention in this study.
The Fifth People's Hospital of Nanhai District, Foshan City	Other: No interventions; All procedures are observation. No intervention in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary vertebral fractures	Recording the secondary vertebral fractures	2 years post-operative

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Chunhai Li, MD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Spinal Fractures; Fractures, Compression
• Other Study ID Numbers: SYSKY-2023-1155-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No