ClinicalTrials.gg
Status unknownNCT03369288Updated Oct 30, 2018

Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up

An interventional study of PET MRI in Vertebral Fracture and Cement Augmentation, sponsored by University of Zurich. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-30.

Sponsored by University of Zurich · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.

02

Conditions studied

  • Vertebral Fracture
  • Cement Augmentation

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03

In context

Spinal Fractures

144 studies on the registry are indexed under Spinal Fractures; 24 are open to participants now.

This study's planned enrollment of 30 is below the median of 85 across 85 interventional studies indexed under Spinal Fractures.

Browse Spinal Fractures studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,050 studies on the registry; 134 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • Men and women aged 18 to 70 years
  • Minimum 3-year follow-up
  • Single-level vertebral kyphoplasty
  • Index surgery at UniversitätsSpital Zürich
  • MRI-scan during initial treatment
  • provided

Exclusion criteria

Exclusion criteria

  • Combined with other operative procedure on the spine (e.g. dorsal instrumentation)
  • Intraoperative intradiscal cement leakage
  • Previous history of spinal surgery except on the cervical spine
  • disease with skeletal involvement
  • Known chronic diseases of the bone metabolism other than osteoporosis
  • Documented pregnancy (see also 6.3)
  • Presence of implants not suited for MRI (pacemaker, neuro-stimulators, pain pumps, insulin pumps, Cochlea implants, metallic foreign bodies like bullet fragments)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

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

Interventions

  • Diagnostic testPET MRI

    18F-fluoride PET-MRI

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What researchers measure

Primary outcomes

  1. Tracer Uptake

    Perifokal tracer uptake at the cement-bone border

    Time frame: at least 3 years after kyphoplasty

Secondary outcomes

  1. Intravertebral Discs

    Tracer uptake within the intravertebral disc and morphological changes

    Time frame: at least 3 years after kyphoplasty

07

Study locations

1 of 1 sites recruiting
  • Division of Trauma Surgery, University Hospital Zurich
    Zürich, 8091, Switzerland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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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 2017 (actual). Primary completion is estimated for Jun 2019, 18 months after the start.

Of 36 interventional studies with no phase under Spinal Fractures, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 70. This study's planned 18 months is below that.

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

Registered
Dec 5, 2017
First posted
Dec 11, 2017
StartActual
Dec 5, 2017
Primary completionEst.
Jun 28, 2019
CompletionEst.
Nov 28, 2019
Last update
Oct 30, 2018
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 Oct 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03369288
Responsible party
Sponsor
First posted
Dec 11, 2017
Start date
Dec 5, 2017
Primary completion
Jun 28, 2019 (estimated)
Completion
Nov 28, 2019 (estimated)
Last update
Oct 30, 2018

Study contacts

Georg Osterhoff, MD
Contact
georg.osterhoff@usz.ch
0041 44 255 11 11

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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