Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PVP/PKP.
- Who it may be relevant to
- Registry conditions: Osteoporosis Fracture, Osteoporosis Vertebral, Compression Fracture, Perform PVP / PKP Treatment. Basic parameters: 50 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures: a Multicenter Prospective Cohort Study
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).
Interventions
- Procedure PVP/PKP
PVP or PKP surgery in patients with osteoporotic vertebral compression fractures
Primary outcome measures
- Non-operative vertebral re-fracture within 1 year after PVP / PKP [Time frame: 1 year]
Secondary outcome measures (2)
- Visual Analog Score (VAS) at 1 year after PVP/ PKP [Time frame: 1 year]
- Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP [Time frame: 1 year]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- The Seventh Affiliated Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT06379243 · KY-2023-008-02