“Shape Memory” orthopaedic device company MedShape, Inc., has reported on the first wave of clinical outcomes in patients who have received the DynaNail(®) TTC Fusion System.
Background
MedShape, Inc. is a developer and commercializer of surgical solutions that use its patented “shape memory” technologies to address the increasing demand for improved sports medicine, joint fusion, and musculoskeletal trauma products.
One such device is the Dynanail TTC fusion system in which the internal nickel titanium (NiTiNOL) element maintains the target fusion bones in close apposition and under sustained compression. DynaNail is the only TTC fusion device to harness the superelastic properties of NiTiNOL. Its internal NiTiNOL element allows for compression to be maintained across the joint post-operatively by automatically adapting to loading changes due to settling or resorption. In addition, the ultra-low axial stiffness of the NiTiNOL element automatically dynamizes the joint, and mitigates stress-shielding that is universal to all other intramedullary nails on the market.
To date during its targeted soft launch period, DynaNail has been successfully implanted in over 100 tibiotalocalcaneal (TTC) fusion procedures. Successful fusions are being observed with the DynaNail TTC Fusion System in high-risk patients, specifically those who require bone allografts.
Achieving fusion using an allograft has previously proven challenging, particularly in high-risk patients with degenerative bone conditions or who are immuno-compromised, studies showing up to a 50% non-union rate in patients who underwent TTC fusion when an allograft was used and no fusions when the graft was used on diabetic patients.
It’s striking then to see a large number of these high-risk patients reportedly experiencing fusions with DynaNail, as confirmed by CT scan, including many with bulk allografts.
Physician comments
Dr. Thomas San Giovanni of the UHZ Sports Medicine Institute in Coral Gables, Fla. has implanted DynaNail in five patients, using a femoral head allograft for three, with successful fusion in each.
“I believe we may be entering a new era within orthopedics where the unique properties of certain materials such as NiTiNOL will be used to our advantage to assist in the healing of bone – complementing both the mechanical and biologic nature of bone healing,” said Dr. San Giovanni. “The DynaNail is the first product of its kind and certainly is on the brink of this technology. I’ve had very good success with the DynaNail in some of the most difficult clinical scenarios where combined arthrodesis of the ankle and subtalar joint was needed. It has become my preferred fixation method when using a nail for TTC fusions. I have been very impressed by its performance and foresee the technology and unique properties of this nail lending itself to many future applications, even for other conditions.”
Dr. Eric Giza at the University of California Davis in Sacramento, Calif., has also used DynaNail in three TTC fusion procedures. In his first case he used a fibular autograft, and for the second case he implanted a synthetic trabecular metal spacer due to severe bone loss. At four months, there is evidence of fusion for both patients while the third patient is still outside the fusion window.
“I have found that the maintenance of compression from DynaNail has led to impressive stability for complex cases,” said Dr. Giza.
Dr. Samuel Adams from Duke University in Durham, N.C. first used DynaNail based on its sustained compressive power. Dr. Adams has implanted DynaNail in five patients, all using a bone allograft.
“The DynaNail is an unrivaled orthopedic device and my implant of choice for hindfoot arthrodeses,” stated Dr. Adams. “No other hindfoot fusion device allows for intraoperative compression and accounts for postoperative bone resorption through sustained dynamic compression. It’s amazing to ‘see’ the DynaNail at work!”
Source: MedShape, Inc., PR Newswire
published: January 7, 2014 in: Clinical Studies/Trials, Extremity