Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Os… (NCT04495439) | Clinical Trial Compass
TerminatedNot Applicable
Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures
Stopped: Change in company strategy
Austria2 participantsStarted 2019-09-11
Plain-language summary
Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone interface, the ISS stabilization system has been developed. The goal of the study is to investigate the efficacy the ISS augmentation compared to the standard PMMA augmentation of pedicle screws in the treatment of patients suffering from osteoporotic/osteopenic thoracolumbar fracture.
The study has two phases, a pilot phase followed by a pivotal phase. The data will be used to measure clinical and radiological performance and usability of both systems.
Who can participate
Age range50 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age ≥ 50 and ≤ 85, male and female patients
✓. 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 procedures.
✓. Fractures between the 10th thoracic and 4th lumbar vertebra, both included
✓. Bone mineral density equal or above the threshold of 60 mgHA/ccm (central assessment of the screening qCT scan).
✓. Fractures with the indication and possibility for augmented bi-segmental dorsal pedicle screw and rod stabilization including kyphoplasty in the broken vertebra
✓. All fractures where pedicle screws can be used
Exclusion criteria
✕. Substance use disorders (incl. tobacco abuse \>20 cigarettes/day) and alcohol abuse disorders within the last 2 years before randomization.
What they're measuring
1
Change of the bi-segmental kyphosis angle (Correction Loss)