ClinicalTrials.gg
Sign In
RecruitingNCT06379243Updated Apr 23, 2024

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

An interventional study of PVP/PKP in Osteoporosis Fracture, Osteoporosis Vertebral and Compression Fracture, sponsored by The Seventh Affiliated Hospital of Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by The Seventh Affiliated Hospital of Sun Yat-sen University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Dec 2023, registered Apr 2024).
  • Started Dec 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
560
Allocation
Not applicable
Ages
50 Years to 90 Years
Sex
All
01

Study 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).

02

Conditions studied

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

Keywords

  • osteoporosis
  • spinal vertebral fractures
  • PVP / PKP treatment
03

In context

Osteoporotic Fractures

87 studies on the registry are indexed under Osteoporotic Fractures; 22 are open to participants now.

This study's planned enrollment of 560 is above the median of 120 across 49 interventional studies indexed under Osteoporotic Fractures.

Browse Osteoporotic Fractures studies →

Lead sponsor

The Seventh Affiliated Hospital of Sun Yat-sen University is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
560 participants (estimated)

Study arms

  • Experimental
    non-operative vertebra refracture

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

    Procedure: PVP/PKP

Interventions

  • ProcedurePVP/PKP

    PVP or PKP surgery in patients with osteoporotic vertebral compression fractures

06

What researchers measure

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

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • The Seventh Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2023 (actual). Primary completion is estimated for Dec 2026, 36 months after the start.

Of 22 interventional studies with no phase under Osteoporotic Fractures, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 60. This study's planned 36 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2024
First posted
Apr 23, 2024
StartActual
Dec 1, 2023
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2027
Last update
Apr 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06379243
Lead sponsor
The Seventh Affiliated Hospital of Sun Yat-sen University
Collaborators
The Fourth Affiliated Hospital of Guangzhou Medical University, Huizhou Municipal Central Hospital, Dongguan Hospital of Traditional Chinese Medicine
Responsible party
Qingyu Liu (chief physician, The Seventh Affiliated Hospital of Sun Yat-sen University) — Principal investigator
First posted
Apr 23, 2024
Start date
Dec 1, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 23, 2024

Study contacts

jinhui cai
Contact
caijinhui123456@163.com
+86 18002299663
qingyu liu
principal investigator · The Seventh Affiliated Hospital of Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Osteoporotic Fractures →

Other studies from this sponsor

The Seventh Affiliated Hospital of Sun Yat-sen University

Start the discussion