Actively Recruiting

Phase Not Applicable
Age: 50Years - 90Years
All Genders
NCT06379243

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

Led by The Seventh Affiliated Hospital of Sun Yat-sen University · Updated on 2024-04-23

560

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

Sponsors

T

The Seventh Affiliated Hospital of Sun Yat-sen University

Lead Sponsor

G

Guangzhou Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with osteoporotic vertebral fractures of the thoracic and lumbar level with reference to the 2022 edition of the Osteoporotic Fractures Guidelines (2022 edition)
  • Presence of bone marrow edema or hemorrhage (acute fracture) in the fractured vertebrae clearly defined by MR examination
  • Responsible vertebrae treated with PVP or PKP
  • Number of fractured vertebrae: 1-3 vertebral compression fractures (including old fractures)
Not Eligible

You will not qualify if you...

  • History of severe scoliosis, vertebroplasty, or internal spinal fixation
  • Presence of spinal infection and malignant neoplastic disease
  • Presence of mental disease, cognitive impairment, or critical illness (e.g., severe cardiac or cerebrovascular disease)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Seventh Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Actively Recruiting

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Research Team

J

jinhui cai

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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