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NCT Number: NCT06379243

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

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).

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Seventh Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Kuiqing Lu

CONTACT

[email protected]

0755-81207263

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PVP/PKP

Procedure

PVP or PKP surgery in patients with osteoporotic vertebral compression fractures

Primary outcomes

  1. Non-operative vertebral re-fracture within 1 year after PVP / PKP

    Time frame: 1 year

    Non-operative vertebral re-fracture within 1 year after PVP / PKP, confirmed by follow-up spinal MRI

Secondary outcomes

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

    Time frame: 1 year

    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.

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

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

jinhui cai

CONTACT

[email protected]

+86 18002299663

Sponsors and collaborators

Lead sponsor

The Seventh Affiliated Hospital of Sun Yat-sen University

Other

Collaborators

  • Dongguan Hospital of Traditional Chinese Medicine
  • Guangzhou Medical University
  • Huizhou Municipal Central Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 23, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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