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

The Seventh Affiliated Hospital of Sun Yat-sen University560 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

560

Conditions

Osteoporosis Fracture Osteoporosis Vertebral Compression Fracture Perform PVP / PKP Treatment

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Non-operative vertebral re-fracture within 1 year after PVP / PKP

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

Time frame: 1 year

Secondary Outcomes

Visual Analog Score (VAS) at 1 year after PVP/ PKP

Visual Analog Score (VAS) at 1 year after PVP / PKP were obtained by completing the appropriate questionnaires on-site at the time of the 1-year postoperative spinal MRI review.

Time frame: 1 year

Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP

Oswestry Dysfunction Index (ODI) at 1 year after PVP / PKP were obtained by completing the appropriate questionnaires on-site at the time of the 1-year postoperative spinal MRI review.

Time frame: 1 year

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts