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Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures

NCT06379243 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2024-04-23

No results posted yet for this study

Summary

In this project, IDEAL-IQ technology and PDFF and R2\* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after PVP / PKP, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after PVP / PKP. To construct a precise and individualized risk assessment model of vertebral re-fracture after PVP/ PKP by combining clinical risk factors, preoperative quantitative MRI parameters (PDFF, R2\*) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year).

Conditions

  • Osteoporosis Fracture
  • Osteoporosis Vertebral
  • Compression Fracture
  • Perform PVP / PKP Treatment

Interventions

PROCEDURE

PVP/PKP

PVP or PKP surgery in patients with osteoporotic vertebral compression fractures

Sponsors & Collaborators

  • Guangzhou Medical University

    collaborator OTHER

  • Huizhou Municipal Central Hospital

    collaborator OTHER

  • Dongguan Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • The Seventh Affiliated Hospital of Sun Yat-sen University

    lead OTHER

Principal Investigators

  • qingyu liu · The Seventh Affiliated Hospital of Sun Yat-sen University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06379243 on ClinicalTrials.gov