MedShape, Inc. a shape memory orthopedic device company headquartered in Atlanta, Georgia, recently announced promising clinical data from two studies that highlights the effectiveness of the DynaNail TTC Fusion system with its super elastic NiTiNOL (nickel titanium) technology in high risk patients who need tibiotalocalcaneal (TTC) fusion.
DynaNail’s technology makes it possible to keep up active compression after surgery as well as reduce the risk of stress shielding.
One study was published in the Foot & Ankle Specialist. In “Comparison of Tibiotalocalcaneal Arthrodeses Using a Sustained Dynamic Compression Nail Versus Nondynamized Nails,” patients who underwent TTC fusion surgery with the DynaNail were able to achieve fusion a few months faster than those who had TTC fusion with a non-dynamized intramedullary nail (IM), despite the fact that the DynaNail group had risk factors for nonunion.
The other study, “Tibiotalocalcanel Arthrodesis Utilizing a Titanium Intramedullary Nail With an Internal Pseudoelastic Nitinol Compression Element: A Retrospective Case Series of 33 Patients,” was published in the Journal of Foot & Ankle Surgery.
The authors here reported that 90% of the 33 patients were able to achieve fusion with DynaNail despite the fact that many of the patients were considered high risk because of multiple comorbidities and previous fusion failures.
The authors wrote that the DynaNail is “safe and effective in generating axial compression across both tibiotalar and subtalar joints in TTC arthrodesis.”
MedShape Director of Clinical Research Kenneth Dupont, Ph.D., said, “We are pleased to add these recent studies to DynaNail’s clinical arsenal as they represent the strongest evidence to date of DynaNail’s efficacy and superiority over competitor IM nails for tibiotalocalcaneal arthrodesis.”
He added, “Combined with an already sizeable amount of peer-reviewed, published data, these studies indicated the combination of sustained joint compression and immediate dynamization provide a mechanobiological input which can potentially lead to improved patient outcomes, especially in the most challenging cases. This suggests that the old refrain of ‘a nail is a nail’ no longer applies when DynaNail is available as part of a surgeon’s tool kit.”
On why the NiTiNOL technology is so effective even in high risk patients, Dupont told OTW, “Successful joint fusion requires stable apposition of bone ends with high contact area. This maintained contact requires sufficient compression to be directly applied to the bone ends throughout the healing process in order to fuse. NiTiNOL exhibits a property called pseudoelasticity, which results in medical devices made of the material being able to sustain a compressive load when stretched to a certain point and released. This sustained compression is especially important for high risk patients such as diabetics that can have impaired healing responses and increased bone resorption at the joint interface, challenging the fusion process.
“Non-dynamized, static nails have no mechanism to maintain compression following resorption, such that gaps can form between bone ends. These gaps lead to nonunion and potential implant failure, as the hardware then transmits all of the loads caused by weight bearing. In contrast, DynaNail’s NiTiNOL element, which is dynamized from the point of surgery, allows DynaNail to actively sustain compression through up to 6mm of bone resorption, maintaining bone on bone contact.”
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