The VersaNail® System

Are you considering ankle fusion surgery? If so, your surgeon may suggest a procedure called tibiotalocalcaneal (TTC) fusion and the VersaNail System.

Tibiotalocalcaneal fusion differs from a traditional ankle fusion. In traditional ankle fusion surgery, the ankle joint is removed, allowing the tibia (shinbone) to grow together, or fuse, with the talus bone (the first large bone of the foot).

In TTC fusion, the tibia, talus and calcaneal bones are fused together using sophisticated metal implants called intramedullary nails (intradmedullary means within the bone). DePuy Orthopaedics offers a TTC implant called the VersaNail^® that is made of high-tech metals (titanium alloy). Using this system, surgeons can adapt the implant for the specific size and anatomy of each patient, and help achieve optimum alignment of the bones of the foot and ankle.

The VersaNail System is a complete system of surgical instruments and implants for surgeons to use with TTC fusion surgery. The system was designed in consultation with orthopaedic specialists and integrates clinical research and engineering with advanced materials, techniques and anatomical design. Because every patient is different, and because the anatomy of the foot and ankle are very complex, the VersaNail System provides a range of implant sizes and instrument versatility, giving surgeons more choices for their patients.

How does the VersaNail System Work?

In TTC surgery using the VersaNail System, the surgeon inserts the VersaNail implant into the patient’s foot and ankle, through an incision in the bottom of the foot (see related article detailing the surgical procedure). The VersaNail implant is slightly larger than the diameter of a pencil and from 6 to 10 inches long. Special holes in the side of the VersaNail accommodate five screws used to secure the implant in the patient’s ankle and shin bone. When inserted, the implant’s purpose is to firmly secure (or fuse) the heel and the ankle joints much like a nail secures two pieces of wood.

Why choose the VersaNail System?

Surgeons want options, and in precision surgery like TTC fusion, details make a big difference:

• The VersaNail System uses a special design to produce screws that are smaller, yet just as strong, as other surgical-use screws. This allows the surgeon to place three screws at that portion of the foot for better fixation. The screws help eliminate rotation, preventing the largest bone in the heel (the one that forms the round part of the heel) from “rocking” on the implant when the patient puts weight on it.
• The implant is designed to allow surgeons the choice of placing screws from different positions in the anatomy, and to make ultra-fine adjustments during surgery.
• The VersaNail is made of a highly specialized metal alloy called 6Al-4V ELI grade, proprietary type II anodized (TiMAX) titanium alloy. This material offers increased strength over stainless steel, and decreased risk for metal sensitivity in patients, which can be important for many people.
• TTC fusion is often used in complex or advanced cases. The procedure requires great precision, and for surgeons to do their best work, they need the most advanced “tools.” The professionals at DePuy Orthopaedics consulted with surgeons trained in foot and ankle surgery to help create surgical instruments for the TTC fusion procedure. The surgical instrumentation can be as important as the implant, because it allows the surgeons to do their best work.

TTC fusion has gained popularity and acceptance among surgeons for some patients. Surgeons who perform TTC fusion can offer patients the advantages of the design, materials and instrumentation that are only offered with the VersaNail System.

TTC fusion is not for every patient, and only an orthopaedic surgeon can determine the right method. As with any surgery there are risks, and results will vary from patient to patient.

Who is a Candidate for TTC Fusion with the VersaNail System?

The VersaNail is used with TTC fusion for patients with advanced osteoarthritis or rheumatoid diseases, injuries from accidents, ankle deformity, and complications from diabetes (Charcot), as well as to treat conditions such as talar avascular necrosis.

TTC is generally used in advanced cases (called “end-stage ankle disorder”) where more conservative treatments like medication have not worked. It is also indicated for some patients who have had prior surgeries with inadequate results. Only a surgeon trained in foot and ankle can determine whether a patient is a candidate for TTC fusion.

Note

Only a surgeon trained in foot and ankle surgery with current surgical skills can provide advice about whether TTC Fusion and the VersaNail System are right for you. See your physician to learn more.

Individual results with any medical treatment may vary from the outcomes mentioned in this article. Please consult with your physician about the advisability of any medical treatment that you are considering.

Warnings and Precautions

Device cannot be expected to withstand the unsupported stresses of full weight bearing. External support and restricted physical activities should be employed until firm bone union is achieved. Proper implant selection should be made for size and shape limitations. Implants should not be bent, notched or scratched during implantation and handling. If other metallic devices are used, they should be manufactured from a similar metal to avoid galvanic corrosion. NO METALLIC IMPLANT SHOULD BE REUSED. Patient should receive detailed instructions on the use and limitations of the device. Since intramedullary nails are not designed as long-term, weight bearing implants they should be removed after fusion occurs whenever possible.

Adverse Effects

The following are the most frequent adverse effects involving the use of intramedullary nails:

Loosening, bending, cracking or fracture of the nail or loss of fixation due to nonunion or osteoporosis; loss of anatomic position with nonunion or malunion with rotation or angulation; infection; allergies and other reaction to the device material.  

References

1. Data on file at DePuy Orthopaedics, Inc.

Last Updated: 09/03/2008