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

NCT06379243 | Recruiting

• 1 other identifier: KY-2023-008-02
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoporosis Fracture; Osteoporosis Vertebral; Compression Fracture; Perform PVP / PKP Treatment

Keywords

osteoporosis; spinal vertebral fractures; PVP / PKP treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Analog Score (VAS) at 1 year after PVP/ PKP

  1 year

• Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP

  1 year

Study Arms (1)

non-operative vertebra refracture

EXPERIMENTAL

observe non-operative vertebra refracture after PVP/PKP surgery.

Procedure: PVP/PKP

Interventions

PVP/PKP PROCEDURE

PVP or PKP surgery in patients with osteoporotic vertebral compression fractures

non-operative vertebra refracture

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Seventh Affiliated Hospital of Sun Yat-sen University: lead
• Guangzhou Medical University: collaborator
• Huizhou Municipal Central Hospital: collaborator
• Dongguan Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

The Seventh Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Osteoporotic Fractures; Fractures, Compression; Osteoporosis

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• qingyu liu

  The Seventh Affiliated Hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jinhui cai

CONTACT

+86 18002299663; caijinhui123456@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 23, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)