Fiber-reinforced fixation implant for proximal interphalangeal joint arthrodesis shows implant bio-integration at 1-year follow-up

Background A new bio-integrative fiber-reinforced implant (OSSIOfiber® Hammertoe Fixation Implant, OSSIO Ltd., Caesarea, Israel) was developed for proximal interphalangeal joint (PIPJ) correction-arthrodesis. The main purpose of this clinical study was to assess implant bio-integration at 1-year follow-up. Methods Twenty-four patients, previously treated for a Hammertoe deformity using the bio-integrative, fiber-reinforced implant, were enrolled in this follow-up study. One-year follow-up included clinical examination, patient reported outcomes, radiographs, Magnetic Resonance Imaging (MRI) and bio-integration scoring. Results Proximal interphalangeal joint (PIPJ) radiographic fusion rate was 92% (n = 22). MRI was analyzed for 24 (100%) patients. In 100% of patients (n = 24), the border between implant and surrounding tissue was scored as partially visible. There were no cyst formation or fluid accumulation findings. Mild bone edema was detected in 29% (n = 7) and is attributed to the chronic distribution of forces due to chronic abnormal gait and pasture. None of the edema findings were considered as adverse implant-related finding. The mean bio-integration score was 7.71 ± 0.46. Conclusions This study demonstrates safe bio-integration of the newly developed fiber-reinforced implant at 1-year follow-up without negative side effects.