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NCT03369288 Clinical Trial

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

Vertebral Fracture Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03369288
Other study ID # 2017-01207
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 5, 2017
Est. completion date November 28, 2019

Study information
Verified date October 2018
Source University of Zurich
Contact Georg Osterhoff, MD
Phone 0041 44 255 11 11
Email georg.osterhoff@usz.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date November 28, 2019
Est. primary completion date June 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• PET MRI
18F-fluoride PET-MRI

Locations
Country Name City State
Switzerland Division of Trauma Surgery, University Hospital Zurich Zürich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tracer Uptake Perifokal tracer uptake at the cement-bone border at least 3 years after kyphoplasty
Secondary Intravertebral Discs Tracer uptake within the intravertebral disc and morphological changes at least 3 years after kyphoplasty
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