Vertebroplasty Compared With a Sham-procedure for Painful Acute Osteoporotic Vertebral Fractures (NCT01537770) | Clinical Trial Compass
CompletedNot Applicable
Vertebroplasty Compared With a Sham-procedure for Painful Acute Osteoporotic Vertebral Fractures
Denmark52 participantsStarted 2012-02
Plain-language summary
The main purpose of this study:
\- to determine whether vertebroplasty has a pain palliating effect superior to a sham-procedure for acute painful osteoporotic vertebral fractures of the thoracic and lumbar spine.
Secondary purposes:
* To determine if there are differences in the two methods on preventing forward tilting of the spine and/or shortening of the total height of the spine.
* measure if there are differences in change of lung capacity between the two methods
Who can participate
Age range
50 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:
* VCF on X-ray of the spine (minimal 15% loss of height) level of VCF Th6 or lower
* back pain ≤ 8 weeks at time of surgery
* ≥ 50 years of age
* bone edema on MRI of the fractured vertebral body
* focal tenderness on VCF level
Exclusion Criteria:
* severe cardio-pulmonary condition
* untreatable coagulopathy
* systemic or local infection of the spine (osteomyelitis, spondylodiscitis)
* suspected alternative underlying disease (malignancy)
* radicular and/or cauda compression syndrome
* contra-indication for MRI
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.
1This trial compared vertebroplasty to a sham procedure for painful osteoporotic vertebral fractures — what did the results actually show about whether vertebroplasty provided meaningful pain relief compared to the fake procedure, and how does that affect whether it might help me?
2Since this study is now completed, has the evidence from it changed the way you would recommend treating my type of fracture, or do you still consider vertebroplasty a strong option for me?
3The trial focused specifically on acute osteoporotic vertebral fractures — does my fracture fit that same profile in terms of timing and bone density, and does that change how relevant these findings are to my situation?
4Given that a sham procedure was used as the comparison, what does that tell us about the role of the placebo effect in vertebroplasty, and should that factor into the decision about whether I pursue it?
5Are there standard non-surgical treatments — like pain medication, bracing, or physical therapy — that I should try first before we consider vertebroplasty, especially in light of what this trial found?
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.