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First-in-Human, Prospective, Multicenter Clinical Study

OSSIO is thrilled to announce the publication of our prospective, multicenter, first-in-human clinical trial in Foot & Ankle Orthopaedics. 

 

Prospective, Multicenter, Clinical and Radiographic Evaluation of a Biointegrative, Fiber-Reinforced Implant for Proximal Interphalangeal Joint Arthrodesis
Luke D. Cicchinelli, DPM, Jurij Štalc, MD, Martinus Richter, MD, PhD, Stuart Miller, MD

 

Twenty-five patients underwent PIPJ fusions with OSSIOfiber Hammertoe Fixation Implants. Primary performance endpoints were radiographic PIP joint fusions and secondary endpoints included patient-reported outcome measures with follow-up at 2, 4, 6, 12, and 26 weeks postoperatively, as well as overall patient satisfaction scores. A second, longer term study is anticipated publication in 2021. 

 

Key Findings:

  • All operated joints (100%) were evaluated as clinically stable, with excellent bony fusion rate (88%) at 26 weeks, which is of the highest published fusion rates for hammertoe fixation solutions.
    • Absorbable intramedullary implants - Averaged 82%
    • Allograft implants - Averaged 77%
    • Nitinol implants – Averaged 79%

    • Metal Implants – Averaged 74%

    • K-Wire fixation – Averaged 61%

  • No complications or serious adverse events, no withdrawals from the study 
  • Substantial patient-reported improvements in pain and function 
  • 100% of patients matched or exceeded their expectations for postoperative results and were likely to choose this implant again

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Topics: Hammertoe Fixation System

Orahn Preiss-Bloom, Founder and Chief Innovation Officer
Orahn Preiss-Bloom, Founder and Chief Innovation Officer
Orahn is the Founder and Chief Innovation Officer at OSSIO. Previously, as founder and COO/CTO of LifeBond, Orahn developed two biosurgical product families to commercial stage and raised $60M, including from Johnson & Johnson Development Corporation. Prior, he was a biomechanics researcher at IDF Institute for Military Physiology and at Columbia University NY, Dept. of Orthopedic Surgery. Orahn has an M.Sc. in biomedical engineering from the Technion, Israel Institute of Technology.

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