Study About the Effect of Preventive Adjacent Level Cement Augmentation After Osteoporotic Verteb… (NCT02489825) | Clinical Trial Compass
TerminatedPhase 4
Study About the Effect of Preventive Adjacent Level Cement Augmentation After Osteoporotic Vertebral Compression Fractures
Stopped: Death of study initiator
Switzerland100 participantsStarted 2015-01
Plain-language summary
Vertebroplasty itself is challenged regarding its clinical efficacy. While two randomized controlled trials (RCTs) with substantial methodological problems have led to an intense discussion another RCT with larger case numbers, more representative inclusion criteria and a more consistent and sound methodology has revealed results that mirror the investigators' own clinical experience. In their daily practice, the investigators have further advanced their treatment concept and routinely apply prophylactic augmentations with VP using an algorithm. Biomechanical studies support their approach, but clinical studies are rare so far. Prophylactic augmentation with balloon kyphoplasty has not shown convincing effects in a small pilot study. Given the above mentioned methodological and clinical disputes and the call for high-evidence studies about VP, the investigators aim at generating a reliable sample size calculation and preliminary results for a future multicenter RCT about prophylactic adjacent level augmentation with VP in single level osteoporotic compression fractures.
Who can participate
Age range
55 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:
* Age ≥ 55 years
* Written informed consent
* Single level acute (\< 6 weeks) vertebral compression fracture
* Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis
* Patients with Association for the study of Osteosynthesis (AO) type A1.x fractures and A3.1 fractures may be included in the study
* Target Vertebral Compression Fracture (VCF) is between T10 and L4
* Target VCF to be treated shows either: height change - an acute (\< 6 weeks) change in VB height (\>15% height loss) with height loss at the anterior or middle portion of the VB consistent with a worsening of 1 or more grades acc to Genant
* OR positive MRI or bone scan - VB shows hyperintense signal on MRI-T2 or STIR sequence
* OR target VB is positive on radionuclide bone scan
* Back pain correlating with the location of the VCF
* Treatment of target and adjacent VCFs is technically feasible by and clinically appropriate for vertebroplasty
* No previous VCFs
* No major surgery of the spine planned for at least 6 months following enrollment
* Pre-treatment back pain by numerical rating scale (NRS) score \> 4 (0-10 scale)
* Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent
* Psychosocially, mentally and physically able to fully comply with the protocol requirements for the duration of the study including adhering to scheduled visits, treatment plan, completing forms and other study p…
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.
What they're measuring
1
Number of new operations within 6 months after vertebroplasty due to adjacent or distant segment fracture.