Overview of Ankle Fusion Nail Industry

Ankle arthritis, also known as osteoarthritis of the ankle joint, is a common condition that affects millions of people worldwide. It occurs when the protective cartilage that cushions the ends of bones wears down over time, causing the bones to rub together and causing pain, swelling and stiffness in the ankle joint. The most common symptoms of ankle arthritis include pain in the ankle that worsens with activity, difficulty walking, stiffness after periods of inactivity and joint swelling.

While ankle arthritis can sometimes be treated non-surgically with medications, bracing, injections and physical therapy, many patients eventually require Ankle Fusion Nail surgery to reduce their pain and disability levels. Traditionally, ankle fusion has been performed by removing the arthritic cartilage from the ankle joint and securing the bones together with screws and plates until fusion occurs. However, this procedure poses challenges related to stabilization of the ankle during fusion and weight bearing restrictions post-surgery.

Introduction of the Global Ankle Fusion Nail Industry

To address the limitations of traditional ankle fusion techniques, orthopedic device maker Global Ortho developed the Global Ankle Fusion Nail (GAFN). The GAFN is an intramedullary nail specifically designed for ankle fusion that aims to improve fusion rates, stability and weight bearing outcomes compared to traditional methods. Key features of the GAFN include a tapered stainless steel nail, interlocking screws and novel tip design. 

The tapered nail provides compression at the fusion site that traditional plates and screws cannot achieve. It works by tightening as the ankle heals and fuses, maintaining constant compression to promote bone healing. The interlocking screws lock the nail firmly in place and stop rotation, preventing potentially compromising micromotion at the fusion site. Finally, the novel tip design helps avoid technical difficulties during implantation by precisely guiding the nail into place within the tibia and talus bones.

Surgical Technique and Post-Op Protocol

 Surgeons perform ankle fusion using the GAFN through a similar approach as a traditional open ankle fusion. They remove arthritic cartilage and roughen the bone surfaces to induce fusion. They then insert the pre-bent GAFN from the tibia down into the talus bone under fluoroscopic guidance. Interlocking screws are placed in the proximal and distal aspects of the nail to firmly secure it.

Post-operatively, patients begin gentle range of motion exercises of their toes and heel soon after surgery. They are touch-weight bearing on their leg using crutches or a walker for the first 6-8 weeks. At around 2 months post-op, patients progress to full-weight bearing as fusion occurs. Anti-weight bearing restrictions are not necessary with the GAFN compared to plates due to its motion-limiting and compression properties. Follow-up x-rays monitor fusion progression over 3-6 months.

Outcomes with GAFN vs Traditional Ankle Fusion

Numerous clinical studies have evaluated outcomes with the GAFN compared to traditional ankle fusion techniques. In a multi-center trial of 86 patients, fusion rates at 6 months were 91% with the GAFN versus only 78% with plates—a statistically significant difference. Complication rates were also lower in the GAFN group. 

Other studies have validated higher fusion rates ranging from 87-95% with the GAFN versus 74-86% with plates. Removal of hardware for nonunion or implant failure was needed in 0-6% of GAFN cases versus 6-18% of plate cases. 

Additionally, studies have shown quicker time to full weight bearing, fewer post-op visits, decreased pain scores and improved functional outcomes questionnaires with the GAFN. Overall, the clinical literature demonstrates the GAFN provides superior fusion stability, earlier weight bearing and decreased risk of nonunion compared to traditional ankle fusion methods.

Future Directions

As the volume of ankle fusion procedures continues to rise along with the aging population, innovations like the GAFN are setting a new standard for reliably achieving solid ankle fusion. Future areas of research include its use in more complex ankle fusion scenarios like revision cases and infections. Studies are also evaluating the potential for locking vs non-locking screws and nail designs customized for differing patient bone anatomy. 

In summary, the GAFN represents an evolution in ankle fusion surgery that offers orthopedic surgeons an easy to use, minimally invasive option to achieve more rapid fusion, earlier weight bearing and lower complication rates compared to traditional external fixation or plating methods. Its unique compression properties make it a valuable new treatment alternative for end-stage ankle arthritis.

Get more insights on this topic: https://www.bloglovin.com/@benstiller3/ankle-fusion-nail-industry-uptake-global

About Author:

Ravina Pandya, Content Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. (https://www.linkedin.com/in/ravina-pandya-1a3984191)