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

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).

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis Fracture; Compression Fracture; Osteoporosis Vertebral; Perform PVP / PKP Treatment
• Intervention / Treatment: Procedure: PVP/PKP

• Study Type: Interventional
• Enrollment (Estimated): 560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jinhui cai; Phone Number: +86 18002299663; Email: caijinhui123456@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Seventh Affiliated Hospital, Sun Yat-sen University
      • Contact: Kuiqing Lu; Phone Number: 0755-81207263; Email: lukq@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: non-operative vertebra refracture; observe non-operative vertebra refracture after PVP/PKP surgery.	Procedure: PVP/PKP; PVP or PKP surgery in patients with osteoporotic vertebral compression fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: The Seventh Affiliated Hospital of Sun Yat-sen University
• Collaborators: Huizhou Municipal Central Hospital; Dongguan Hospital of Traditional Chinese Medicine; The Fourth Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: qingyu liu, The Seventh Affiliated Hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 21, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 21, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: osteoporosis; spinal vertebral fractures; PVP / PKP treatment
• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Spinal Injuries; Back Injuries; Fractures, Bone; Osteoporosis; Spinal Fractures; Fractures, Compression; Osteoporotic Fractures
• Other Study ID Numbers: KY-2023-008-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No