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

Not Applicable

Recruiting

• Conditions: Perform PVP / PKP Treatment; Osteoporosis Fracture; Compression Fracture; Osteoporosis Vertebral
• Interventions: Procedure: PVP/PKP

• Registration Number: NCT06379243
• Lead Sponsor: The Seventh Affiliated Hospital of Sun Yat-sen University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-21
• Last Update Submitted: 2024-04-21
• Study First Posted: 2024-04-23
• Last Update Posted: 2024-04-23
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 560

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
non-operative vertebra refracture	PVP/PKP	observe non-operative vertebra refracture after PVP/PKP surgery.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP	1 year	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.
Visual Analog Score (VAS) at 1 year after PVP/ PKP	1 year	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.

Trial Locations

Locations (1)

The Seventh Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China