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Predicting repeat spinal fracture risk after vertebral cement procedures in osteoporosis

Builds a risk model for repeat spine fracture in adults with osteoporosis treated with cement.

Plain-language title generated from the registry record
Registry title: Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures

Key facts

Where
Guangzhou, ChinaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 50 and 90 years old?

Source: NCT06379243, who can take part

Where in China

  • The Seventh Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
The Seventh Affiliated Hospital of Sun Yat-sen University
Trial code
NCT06379243
Record updated
23 April 2024
Original description
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).Read full original descriptionShow less

Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures: a Multicenter Prospective Cohort Study

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).

Inclusion: 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: 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).

ClinicalTrials.gov NCT06379243