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“Natural Bunion Repair” with OSSIOfiber  Trimmable Fixation Nails; 1st and 5th Metatarsal SCARF Osteotomies

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Dramatic evolution in the understanding of the pathophysiology and treatment of Bunions has occurred in recent years. Surgical treatment of symptomatic bunions continues to undergo a paradigm shift as greater technological opportunities present themselves for the surgical management of foot and ankle disorders, specifically Hallux Valgus. More than ever the psychology surrounding bunion surgery is being evaluated and effective treatment algorithms are being implemented to address not only the technical component to bunion correction, but the psychological element illustrated from the patients’ perspective.

Bunions (Hallux Valgus) are one of the most common forefoot disorders that cause pain and dysfunction. The overall prevalence is approximately 30% in females and 13% in males, with published hardware removal rates at 15-30%1. Hallux Valgus remains a challenging deformity due its inherent nature of producing both physical dysfunction and unpleasant cosmetics. We believe OSSIOfiber presents a tremendous value for patients as it provides a sound fixation with a “natural” result that is bio-integrative. Ultimately this achieves an operative experience that is welcomed from a patient’s perspective and highly rewarding for the surgeon. 

Case Presentation

A 41 year-old, 212 pound female patient presented with a three year history of bunion pain in her right foot. The initial assessment concluded that the hallux became pronated and dorsiflexed due to the lateral deviation of the extensor hallucis longus and contracture of the adductor hallucis longus exacerbated the deformity influencing lateral sesamoid apparatus subluxation. The 1st and 5th metatarsal planned to be addressed with SCARF osteotomies for a medial and dorsal/lateral approach to correct the deformity and relieve the patient’s chronic pain. Concomitantly, a lateral release of the 1st MTP was planned. 

How was OSSIOfiber® utilized for this patient?

The OSSIOfiber® Trimmable Fixation Nail enables customization in patient specific anatomy with the added benefit of complete integration into the native anatomy; eliminating the risks of symptomatic hardware with removal in approximately 15% of cases within a median duration of 9.0 months after surgery2. 

Pre-op Planning

Weightbearing radiographs and clinical parameters were taken.

Figure 1 – 3: Pre-Operative weightbearing later, AP, and sesamoid views of the right foot

Natural Bunion Figure 1-3-1 Post-Operative Protocol

The OSSIOfiber® Trimmable Fixation Nails have replaced the use of 2.4mm headless compression screws for 1st and 5th metatarsal SCARF osteotomies. The Trimmable Nails confidently provide stability and hold necessary compression that can be created from reduction clamps. Thus, post-operative protocol had not been altered from standard protocol.

  • Non-weight bearing splint for 1 week post-operative
  • Weight-bearing boot for 4 – 6 weeks
  • Regular shoe and physical therapy starting at week 6 

Follow-Up Timepoints and Observations

  • 1 Week Post-Operative: The patient presented to clinic at 1 week post-operatively, incisions healing well, pain and swelling at the surgical site was minimal. Motor, sensation, and circulation at the distal extremity was without compromise. The patient was transitioned into a boot walker with bunion splint and allowed to begin heel weightbearing as tolerated. 
  • 4 Weeks Post-Operative: Patient returned to clinic at 4 weeks post-operatively, incisions continue to heal well with expected edema and ecchymosis at the surgical site. Sutures remain in place and will continue to dissolve on their own. Motor, sensation, and circulation to the distal extremity was intact and without complications. The patient transitioned to full protected weightbearing in boot walker at this appointment and entered into physical therapy in the following weeks prior to 3 month follow-up.
  • 3 Months Post-Operative: Patient was seen in clinic at 3 months post-operatively following her “Natural Bunion Repair.” The patient was working with physical therapist since her last appointment and returned to activities which include her regular exercise routine. She was able to run up and down stairs and stated she felt “really good about her foot”. The patient was given a full release to return to her desired shoe preference. Radiographs were taken at this appointment. Patient will follow-up at the 1 year anniversary of her surgery. 

Figure 6-7: 3-month post-operative weightbearing lateral and AP views of the right foot

Image Png Jul 13 2021 06 02 26 85 Pm Ossio – Naturally Transformative Bone Healing
Image Png Jul 13 2021 06 02 34 63 Pm Ossio – Naturally Transformative Bone Healing

Summary

OSSIOfiber® Trimmable Fixation Nails are the optimal choice for SCARF osteotomies. The bio-integrative material enables complete, non-obstructed bone-to-bone fusion and – avoiding the pain, risks, and complications often associated with metal hardware. Experience with a diverse use of the 2.4x30mm, 2.4x50mm, and 4.0x50mm Trimmable Nails for primary and secondary fixation across forefoot, midfoot, and hindfoot procedures have yielded adequate fixation compare to that from standalone metal compression screws. The ability to trim to the desired length allows for customization in patient specific anatomy and broad utility. Instinctually, the early bone attachment and in-growth of bone and tissue into the OSSIOfiber material further “root” the implants into place to support continued stabilization for bone regeneration. With the new environment of elective surgeries with COVID considerations, the provided sterile, disposable instrumentation present convenience and additional safety measures.

Image Png Jul 13 2021 06 04 21 36 Pm Ossio – Naturally Transformative Bone Healing

 

1. Nix S, Smith M, Vicenzino B. Prevalence of hallux valgus in the general population: a systematic review and meta-analysis. J Foot Ankle Res. 2010 Sep 27;3:21. doi: 10.1186/1757-1146-3-21. PMID: 20868524; PMCID: PMC2955707. 

2. Peterson KS, McAlister JE, Hyer CF, Thompson J. Symptomatic Hardware Removal After First Tarsometatarsal Arthrodesis. J Foot Ankle Surg. 2016 Jan-Feb;55(1):55-9. doi: 10.1053/j.jfas.2015.06.001. Epub 2015 Jul 26. PMID: 26215552.

DOC0001626 Rev 01 03/2021

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Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. 

For more on OSSIO and OSSIOfiber, please visit ossio.io or call 833-781-7373 

Gregory C. Berlet, MD, FRCS(C), FAOA

Gregory C. Berlet, MD, FRCS(C), FAOA

Specialty: Orthopedic Surgery (foot and ankle and sports medicine) Titles: Dr. Berlet is the Managing Partner of The Orthopedic Foot and Ankle Center (OFAC), a practice devoted to multi-disciplinary foot and ankle care in Westerville Ohio. He is past Chairman of the Education Committee for the AOFAS and past board member of the AAOS Council on Education. He is a consulting physician for the Columbus Blue Jackets National Hockey League franchise and the former Chief of the Division of Foot and Ankle Surgery at The Ohio State University College of Medicine and Public Health. Research/innovations: The author of more than 150 scientific publications, Dr. Berlet is founding editor of Foot and Ankle Specialist, Foot and Ankle editor of Orthopedics Today and Helio.com and an active reviewer of many journals. Education/training: Dr. Berlet is fellowship-trained in both sports medicine and foot and ankle surgery. He earned a BSc degree from the University of Western Ontario, London, Ontario, Canada. He earned his MD from the University of Calgary, Faculty of Medicine, Calgary, Alberta, Canada. He was a fellow in foot and ankle surgery at Carolinas Medical Center, Charlotte, NC, USA, and a fellow in sports medicine and arthroscopy at the University of Toronto, Ontario, Canada. Dr Berlet is board certified by the American Board of Orthopedic Surgery and The Royal College of Surgeons (Canada). He is an active member of the American Orthopedic Association.

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Footnotes

1. Data on file at OSSIO 2. Clinical study data on file at OSSIO 3. Kaiser, P.B., Watkins, I., Riedel, M. D., Cronin, P., Briceno, J., Kron, J. Y. (2019). Implant Removal Matrix for the Foot and Ankle Orthopaedic Surgeon. Foot & Ankle Specialist, 12(1), 79-97. https://doi.org/10.1177/1938640018791015 4. Pre-clinical animal studies (in-bone implantation of OSSIOfiber® and PLDLA control in rabbit femurs). Data on File at OSSIO. 5. Haddad, S. F., Helm, M. M., Meath, B., Adams, C., Packianathan, N., & Uhl, R. (2019). Exploring the Incidence, Implications, and Relevance of Metal Allergy to Orthopaedic Surgeons. Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews, 3(4), e023. https://doi.org/10.5435/JAAOSGlobal-D-19-00023 6. Pot J, Wensen RV, Olsman J. Hardware Related Pain and Hardware Removal after Open Reduction and Internal Fixation of Ankle Fractures. The Foot and Ankle Online Journal. 2011;4(5). doi:10.3827/ faoj.2011.0405.0001.