Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentati… (NCT03369288) | Clinical Trial Compass
UnknownNot Applicable
Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up
Switzerland30 participantsStarted 2017-12-05
Plain-language summary
3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.