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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorThe Seventh Affiliated Hospital of Sun Yat-sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • PVP/PKP

    Procedure/Surgery

    PVP or PKP surgery in patients with osteoporotic vertebral compression fractures

Treatment groups

560 Participants
are divided into 1 treatment group
Group A: non-operative vertebra refractureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Seventh Affiliated Hospital of Sun Yat-sen University

Lead sponsor

Guangzhou Medical University

Collaborator

Huizhou Municipal Central Hospital

Collaborator

Dongguan Hospital of Traditional Chinese Medicine

Collaborator