Actively Recruiting
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
Eligibility Criteria
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)
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
Trial Site Locations
Total: 1 location
1
The Seventh Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
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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