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Co-Principal Investigator's Overview of First-in-Human Clinical Study

The first-in-human clinical study for OSSIOfiber Intelligent Bone Regeneration Technology was a multicenter, prospective, single-arm study designed to primarily focus on proving the safety and efficacy of the material technology for hammertoe correction arthrodesis. 


At 6 months, the study's results were published in Foot & Ankle Orthopaedic Journal. Hear co-principal investigator, Luke Cicchinelli, DPM, speak to the results of the clinical study at the 1 year time point, which is currently pending publication. 

  • Fusion rate about historical averages 
  • No adverse complications 
  • All measurable scores (FAAM-ADL, Pain VAS) improved from baseline
  • 100% patient satisfaction and willingness to recommend OSSIOfiber to others 



DOC0001415 Rev 01 11/2020

Topics: Hammertoe Fixation System

Luke Cicchinelli, DPM
Luke Cicchinelli, DPM
Luke Cicchinelli, DPM, received his medical degree at Pennsylvania College of Podiatric Medicine and completed his residency for reconstructive foot, ankle, and leg surgery at Emory Northlake Regional Medical Center in Atlanta, GA. He is a Fellow of the American College of Foot and Ankle Surgeons, Australian College of Podiatric Surgery, and has been a guest lecturer across the world. Currently, he is a member of Colegiado en Galicia and Asturias Spain and practices throughout multiples clinics in Spain as a freelance consultant surgeon, coach, and educator. In addition, Dr. Cicchinelli is one of the primary investigators for the first-in-human clinical study for OSSIOfiber Intelligent Bone Regeneration Technology.

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