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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2027-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Osteoporosis Fracture Osteoporosis Vertebral Compression Fracture Perform PVP / PKP Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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non-operative vertebra refracture

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

Group Type EXPERIMENTAL

PVP/PKP

Intervention Type PROCEDURE

PVP or PKP surgery in patients with osteoporotic vertebral compression fractures

Interventions

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PVP/PKP

PVP or PKP surgery in patients with osteoporotic vertebral compression fractures

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No