On Friday the 12th of March, 2021 the first patient of the study was enrolled. The study is a multicenter, prospective, single-blind, randomized, controlled clinical investigation to document the safety and efficacy of the use of V-Flex, a bone cement with adapted stiffness containing Inossia® Cement Softener, in patients with vertebral compression fractures caused by low energy trauma. This trial aims to assess the effectiveness of low-modulus bone cement containing Inossia® Cement Softener, compared to traditional higher-modulus
cement as measured by the reduction of new fractures in patients with symptomatic onelevel T5 to L5 fracture.
Neurosurgeon Dr. Raquel Gutiérrez-González, and her team at Puerta de Hierro University Hospital in Madrid, Spain, performed the first vertebroplasty.
V-Flex, is manufactured by G21 S.r.l. and will be the first Radiopaque Bone Cement for Percutaneous Vertebral Augmentation to include Inossia® Cement Softener. The softener is a universal solution that can be used with any PMMA bone cement existing in the market to adapt it to osteoporotic bone in order to prevent unnecessary adjacent fractures, and their associated pain and high costs. This technology is patented in the EU, US, China, Hong Kong,
India and South Korea.
The clinical trial has been funded by EIT Health SOFTBONE Project 20519.
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