Performance and Safety of Joline® Kyphoplasty Single Balloon Catheter Allevo vs. Quattroplasty Do… (NCT04581707) | Clinical Trial Compass
UnknownNot Applicable
Performance and Safety of Joline® Kyphoplasty Single Balloon Catheter Allevo vs. Quattroplasty Double-Balloon Catheter Stop'n GO With BonOs® Inject Bone Cement
Germany80 participantsStarted 2020-03-01
Plain-language summary
The purpose of this study is to assess the performance and safety of two balloon kyphoplasty systems (Joline®), the single balloon catheter Allevo and Quattroplasty double balloon catheter Stop'n Go, using BonOs® Inject bone cement for treatment of Vertebral Compression Fractures.
Who can participate
Age range
18 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:
* patients aged ≥18 years
* 1-3 painful VCF(s), of which at least 1 meets the following criteria:
* VCF between T7 and L5
* Fracture age \<3 months
* VCF shows hyperintense signal on STIR or T2 sequence MRI.
* Investigator estimates that target VB(s) is/ are suitable for Quattroplasty double balloon catheter or Kyphoplasty single balloon catheter (e.g. appropriate pedicle diameter, no cortical bone protruding into the spinal canal).
* Patient has an ODI score of 30% or more.
* Patient is willing and able to comply with study requirements.
* Patient signs informed consent form.
* Women who are post-menopausal, surgically sterile or on contraceptives and agree to remain on contraceptives for the duration of their study participation and agree not to become pregnant during the study.
Exclusion Criteria:
* Segmental kyphosis of target VB of \>30°
* Pre-existing or clinically unstable neurologic deficit
* Any physical exam evidence of myelopathy or radiculopathy
* Not able to walk without assistance prior to fractures
* Any radiographic evidence of pedicle fracture or interspinous-process widening
* Spondylolisthesis \>grade 1 at target VB(s)
* History of spine surgery, including prior vertebral augmentation, during the last year
* Any underlying systemic bone disease other than osteoporosis (e.g. osteomalacia, osteogenesis imperfect, etc.)
* Irreversible coagulopathy and/or taking peri-operatively warfarin (Coumadin) or other anticoagulant
* Pregnanc…
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
Change in vertebral body height
Timeframe: pre-operative, 5 days and 3 months post-operatively
2
Change in Visual Analog Scale (VAS) of subjective pain
Timeframe: pre-operation, 5 days and 3 months post-operation
3
Change in functional disability
Timeframe: pre-operation, 5 days and 3 months post-operation