Cement Augmentation, Vertebral Fracture
Conditions
Brief summary
3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.
Interventions
DIAGNOSTIC_TESTPET MRI
18F-fluoride PET-MRI
Sponsors
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective PET-MRI follow-up
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tracer Uptake | at least 3 years after kyphoplasty | Perifokal tracer uptake at the cement-bone border |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intravertebral Discs | at least 3 years after kyphoplasty | Tracer uptake within the intravertebral disc and morphological changes |
Countries
Switzerland
Contacts
Primary ContactGeorg Osterhoff, MD
Outcome results
None listed