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