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