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

Primary Purpose

Vertebral Fracture, Cement Augmentation

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
PET MRI
Sponsored by
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vertebral Fracture

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Division of Trauma Surgery, University Hospital ZurichRecruiting

Outcomes

Primary Outcome Measures

Tracer Uptake
Perifokal tracer uptake at the cement-bone border

Secondary Outcome Measures

Intravertebral Discs
Tracer uptake within the intravertebral disc and morphological changes

Full Information

First Posted
December 5, 2017
Last Updated
October 29, 2018
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03369288
Brief Title
Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up
Official Title
Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
June 28, 2019 (Anticipated)
Study Completion Date
November 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Fracture, Cement Augmentation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective PET-MRI follow-up
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
PET MRI
Intervention Description
18F-fluoride PET-MRI
Primary Outcome Measure Information:
Title
Tracer Uptake
Description
Perifokal tracer uptake at the cement-bone border
Time Frame
at least 3 years after kyphoplasty
Secondary Outcome Measure Information:
Title
Intravertebral Discs
Description
Tracer uptake within the intravertebral disc and morphological changes
Time Frame
at least 3 years after kyphoplasty

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georg Osterhoff, MD
Phone
0041 44 255 11 11
Email
georg.osterhoff@usz.ch
Facility Information:
Facility Name
Division of Trauma Surgery, University Hospital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Osterhoff, MD
Phone
+41 44 255 1111
Email
georg.osterhoff@usz.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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

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