Performance and Safety of Joline® Kyphoplasty Single Balloon Catheter Allevo vs. Quattroplasty Do⦠(NCT04581707) | Clinical Trial Compass
UnknownNot Applicable
Performance and Safety of JolineĀ® Kyphoplasty Single Balloon Catheter Allevo vs. Quattroplasty Double-Balloon Catheter Stop'n GO With BonOsĀ® 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 (JolineĀ®), the single balloon catheter Allevo and Quattroplasty double balloon catheter Stop'n Go, using BonOsĀ® Inject bone cement for treatment of Vertebral Compression Fractures.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients aged ā„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
* Pregnancā¦
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