NCT03369288

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

December 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2019

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

December 5, 2017

Last Update Submit

October 29, 2018

Conditions

Vertebral FractureCement Augmentation

Outcome Measures

Primary Outcomes (1)

  • Tracer Uptake

    Perifokal tracer uptake at the cement-bone border

    at least 3 years after kyphoplasty

Secondary Outcomes (1)

  • Intravertebral Discs

    at least 3 years after kyphoplasty

Interventions

PET MRIDIAGNOSTIC_TEST

18F-fluoride PET-MRI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Trauma Surgery, University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Central Study Contacts

Georg Osterhoff, MD

CONTACT

0041 44 255 11 11georg.osterhoff@usz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective PET-MRI follow-up
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 11, 2017

Study Start

December 5, 2017

Primary Completion

June 28, 2019

Study Completion

November 28, 2019

Last Updated

October 30, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)