Compression Fracture, Osteoporosis Fracture, Osteoporosis Vertebral, Perform PVP / PKP Treatment
Conditions
Keywords
osteoporosis, spinal vertebral fractures, PVP / PKP treatment
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).
Interventions
PROCEDUREPVP/PKP
PVP or PKP surgery in patients with osteoporotic vertebral compression fractures
Sponsors
Guangzhou Medical University
Huizhou Municipal Central Hospital
Dongguan Hospital of Traditional Chinese Medicine
The Seventh Affiliated Hospital of Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Contacts
Primary Contactjinhui cai
Outcome results
None listed