Could a new biointegrative implant material reinvent bone healing for common forefoot conditions? OSSIOfiber™ (Ossio), which reportedly received Food and Drug Administration (FDA) clearance earlier this year, offers a regenerative technology, which facilitates bone ingrowth in as little as two weeks and full integration into native bone in 18 to 24 months, according to Ossio, the manufacturer of the product.
With a strong and biointegrative matrix suspended in a poly (L-lactide-co-D, L-lactide) polymer, the company says OSSIOfiber utilizes a microarchitecture of natural mineral fibers that are similar to mineral components found in osteoconductive bone void fillers. Ossio notes that the proprietary technology behind OSSIOfiber is designed to encourage natural bone healing, eliminates hardware removal, prevents stress risers and other typical implant-related complications.
Ossio emphasizes that OSSIOfiber’s composition and design support both biomechanical performance and a favorable environment for bone regeneration. The company adds that this technology has potential applications across the foot and ankle, and does not alter current surgical techniques.
Ossio says its first commercial product featuring this new technology is the OSSIOfiber Hammertoe Fixation System, which includes zero- and 10 degree-angled implants in three sizes (2.5, 2.9, 3.2 mm) with disposable instrumentation. (These new sizes were pending FDA approval at the time of online publication of this article.) The company notes that the implant has the strength required for proximal interphalangeal joint (PIP) fusions while also enabling rapid bone ingrowth, regeneration and complete replacement without the adverse biological reactions one may have seen with earlier generations of non-permanent implants.
Bob Baravarian, DPM, FACFAS, an Assistant Clinical Professor at the UCLA School of Medicine, relates that the OSSIOfiber hammertoe implant has been a positive addition to his practice, noting little to no tissue reaction or edema, and excellent incorporation.
Luke Cicchinelli, DPM, FACFAS, a co-principal investigator of the first human applications of the OSSIOfiber Hammertoe Fixation System, says it has been extremely favorable for hammertoe deformities,specifically PIP joint fusions of the second, third and fourth toes. He cites the lack of need for removal and gradual osseous integration, leaving no remaining implant in the body.
As far as what makes OSSIOfiber unique in the foot and ankle surgery market, Dr. Baravarian points out that it is the only biointegrative product available and does not have the risk factors associated with the typically more brittle allogenic bone. Dr. Cicchinelli cites the improvement in the basic science of resorbable implants and biomaterials, and a design that prevents distraction and rotation across the fusion site.
When asked what he wants fellow surgeons to know about this product, Dr. Baravarian says this is the future of medicine and orthopedics.
“OSSIOfiber will replace metal in the near future....It is a fiber material that fully incorporates and gets replaced with bone,” notes Dr.Baravarian, who has disclosed that he is an investor in Ossio and the head of Ossio’s foot and ankle advisory panel.
Dr. Cicchinelli adds that this implant system appears to be the most updated and innovative version of an ideal resorbable implant to date.
“The future in this field looks very exciting and patients and surgeons alike should benefit tremendously,” adds Dr. Cicchinelli, who is currently in private practice in Vigo, Spain.