Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures

Osteoporosis Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06379243
• Other study ID #: KY-2023-008-02
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: The Seventh Affiliated Hospital of Sun Yat-sen University
• Contact: jinhui cai
• Phone: +86 18002299663
• Email: caijinhui123456[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Compression Fracture
• Fractures, Bone
• Fractures, Compression
• Osteoporosis
• Osteoporosis Fracture
• Osteoporosis Vertebral
• Osteoporotic Fractures
• Spinal Fractures

Intervention

Procedure:
• PVP/PKP
PVP or PKP surgery in patients with osteoporotic vertebral compression fractures

Locations

Country	Name	City	State
China	The Seventh Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
The Seventh Affiliated Hospital of Sun Yat-sen University	Dongguan Hospital of Traditional Chinese Medicine, Huizhou Municipal Central Hospital, The Fourth Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-operative vertebral re-fracture within 1 year after PVP / PKP	Non-operative vertebral re-fracture within 1 year after PVP / PKP, confirmed by follow-up spinal MRI	1 year
Secondary	Visual Analog Score (VAS) at 1 year after PVP/ PKP	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.	1 year
Secondary	Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP	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.	1 year