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Great news for kids: OSSIOfiber® Metal-Free Compression Screws and Trimmable Fixation Nails are now FDA cleared for various bone fractures in children (ages 2-12) and adolescents (ages 12-21). Read More

Compression Screw Performance in a Load-Bearing In Vivo Model

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The objective of this study was to evaluate the performance and mechanical integrity of the
OSSIOfiber® Compression Screw in a full load-bearing osteotomy fixation in an ovine model through 6 months.

 

Key Takeaways:

  • At 2 weeks post-operative, all subjects returned to normal gait and function with X-rays demonstrating stable fixation and good anatomical alignment
  • At 3 months post-operative, all animals demonstrated bony fusion with 100% bone bridging across osteotomy sites, well maintained reduction of the osteotomy and no evidence of implant migration 
  • At 6 months post-operative, all animals showed optimal biocompatibility, maintained structural integrity of the implants and excellent bio-integration with early mesenchymal cellular investment into the implant

Histopathology results at 6 months indicated absence of callus formation, representing healing by first intention, was indicative of a very stable construct, with no signs of implant loosening or migration.

Figure: Micro CT Imaging – Time 0 compared to 6-months post-operative demonstrate
accurate reduction and excellent bone healing and fusion.

Image Png 2 Ossio – Naturally Transformative Bone Healing

 

Discover the comprehensive reviews, X-rays, and micro-CT scans throughout the 6 month study. 

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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Footnotes

1. Data on file at OSSIO 2. Clinical study data on file at OSSIO 3. Kaiser, P.B., Watkins, I., Riedel, M. D., Cronin, P., Briceno, J., Kron, J. Y. (2019). Implant Removal Matrix for the Foot and Ankle Orthopaedic Surgeon. Foot & Ankle Specialist, 12(1), 79-97. https://doi.org/10.1177/1938640018791015 4. Pre-clinical animal studies (in-bone implantation of OSSIOfiber® and PLDLA control in rabbit femurs). Data on File at OSSIO.