NCT06379243Recruiting
Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures
Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures: a Multicenter Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 23 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 560 (estimated)
- First submitted
- 17 Apr 2024
- Start date
- 1 Dec 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- The Seventh Affiliated Hospital of Sun Yat-sen University
- Diseases
- Osteoporosis
- NCT number
- NCT06379243
What you commit to
- Study type: Interventional
- Planned participants: 560
- From 1 Dec 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Who the study is looking for
- 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).
Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Seventh Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.