Klinische Studien

Biointegratives Fiber-Reinforced Intramedulläres Implantat

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, 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.

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