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

October 29, 2018 updated by: University of Zurich
3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8091
        • Recruiting
        • Division of Trauma Surgery, University Hospital Zurich
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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
  • Informed consent provided

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
  • Metastatic 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tracer Uptake
Time Frame: at least 3 years after kyphoplasty
Perifokal tracer uptake at the cement-bone border
at least 3 years after kyphoplasty

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intravertebral Discs
Time Frame: at least 3 years after kyphoplasty
Tracer uptake within the intravertebral disc and morphological changes
at least 3 years after kyphoplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2017

Primary Completion (Anticipated)

June 28, 2019

Study Completion (Anticipated)

November 28, 2019

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 11, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 29, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01207

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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