Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures: a Multicenter Prospective Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 90
Healthy Volunteers: f
View:

• 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);

• The presence of bone marrow edema or hemorrhage (acute fracture) in the fractured vertebrae is clearly defined by MR examination, and the responsible vertebrae is treated with PVP / PKP;

• Number of fractured vertebrae: 1-3 vertebral compression fractures (including old fractures).

Locations
Other Locations
China
The Seventh Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
jinhui cai
caijinhui123456@163.com
+86 18002299663
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 560
Treatments
Experimental: non-operative vertebra refracture
observe non-operative vertebra refracture after PVP/PKP surgery.
Related Therapeutic Areas
Sponsors
Collaborators: Huizhou Municipal Central Hospital, Guangzhou Medical University, Dongguan Hospital of Traditional Chinese Medicine
Leads: The Seventh Affiliated Hospital of Sun Yat-sen University

This content was sourced from clinicaltrials.gov