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

NCT ID: NCT03369288

Last Updated: 2018-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2019-11-28

Brief Summary

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

Detailed Description

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Conditions

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Vertebral Fracture Cement Augmentation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective PET-MRI follow-up
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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PET MRI

18F-fluoride PET-MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Trauma Surgery, University Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Georg Osterhoff, MD

Role: CONTACT

0041 44 255 11 11

Facility Contacts

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Georg Osterhoff, MD

Role: primary

+41 44 255 1111

Other Identifiers

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2017-01207

Identifier Type: -

Identifier Source: org_study_id

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