Status:
UNKNOWN
Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up
Lead Sponsor:
University of Zurich
Conditions:
Vertebral Fracture
Cement Augmentation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03369288
Start Date
December 5 2017
End Date
November 28 2019
Last Update
October 30 2018
Active Locations (1)
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1
Division of Trauma Surgery, University Hospital Zurich
Zurich, Switzerland, 8091