Clinical trial NCT06379243: Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures
Official title: Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures: a Multicenter Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoporosis Fracture
Osteoporosis Vertebral
Compression Fracture
Perform PVP / PKP Treatment
Keywords: osteoporosis
spinal vertebral fractures
PVP / PKP treatment
Lead sponsor: The Seventh Affiliated Hospital of Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guangzhou Medical University
name: Huizhou Municipal Central Hospital
name: Dongguan Hospital of Traditional Chinese Medicine
First posted: 2024-04-23
Enrollment: 560
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


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).

Primary outcomes:
measure: Non-operative vertebral re-fracture within 1 year after PVP / PKP
timeFrame: 1 year
Secondary outcomes:
measure: Visual Analog Score (VAS) at 1 year after PVP/ PKP
timeFrame: 1 year
measure: Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Seventh Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Seventh Affiliated Hospital of Sun Yat-sen University
name: qingyu liu
role: PRINCIPAL_INVESTIGATOR
References: