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

NCT06379243 · tracked via the Priya Life Science China tracker

Sponsor

The Seventh Affiliated Hospital of Sun Yat-sen University

Phase

Not applicable

Started

2023-12-01

Last updated

2024-04-23

Condition(s) studied

Osteoporosis FractureOsteoporosis VertebralCompression FracturePerform PVP / PKP Treatment

Investigational drug(s) / intervention(s)

PVP/PKP

PVP/PKP: PVP or PKP surgery in patients with osteoporotic vertebral compression fractures

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).

Eligibility

Sex

ALL

Min age

50 Years

Max age

90 Years

Healthy volunteers

Inclusion Criteria: * 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). Exclusion Criteria: * 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).

Primary outcome measure(s)

Non-operative vertebral re-fracture within 1 year after PVP / PKP — 1 year
Non-operative vertebral re-fracture within 1 year after PVP / PKP, confirmed by follow-up spinal MRI

Trial sites (1)

Facility	City	Region	Status
The Seventh Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06379243 on ClinicalTrials.gov ↗ ← All trials in China