New clinical findings reported in multiple peer-reviewed studies
| ATLANTA, July 23, 2019 /PRNewswire/ -- MedShape Inc., the industry leader in innovative shape memory orthopedic devices, today announced new clinical findings with the DynaNail® TTC Fusion System. Published in the Journal of Foot & Ankle Surgery and Foot & Ankle Specialist, both studies conclude that the DynaNail, with its patented internal pseudoelastic NiTiNOL technology, is an effective surgical option in tibiotalocalcaneal (TTC) fusions when treating high-risk patients with challenging clinical scenarios.1,2 Both publications represent a clinical milestone for the DynaNail as the first large retrospective studies with long-term follow-up. In the Foot & Ankle Specialist article entitled “Comparison of Tibiotalocalcaneal Arthrodeses Using a Sustained Dynamic Compression Nail Versus Nondynamized Nails,” 86 patients underwent a TTC fusion surgery with an intramedullary nail, 50 with the DynaNail and 36 with a nondynamized intramedullary nail. Compared with the nondynamized nail group, patients who received the DynaNail achieved fusion significantly faster by 3.9 months with a higher fusion rate despite the DynaNail patient group having significantly more risk factors associated with nonunion. According to the authors, all leading foot & ankle specialty-trained surgeons at Duke University, “The [DynaNail] has been shown to achieve successful arthrodesis in a population at high risk for nonunion, using less hardware, and at a faster rate than [nondynamized] nails.” This study proceeds another retrospective study published earlier this year and entitled “Tibiotalocalcaneal Arthrodesis Utilizing a Titanium Intramedullary Nail With an Internal Pseudoelastic Nitinol Compression Element: A Retrospective Case Series of 33 Patients.” Senior authors Kent Ellington, M.D., (OrthoCarolina Foot & Ankle Institute) and John Kwon, M.D., (Harvard Medical) report that 90 percent of all joint surfaces achieved fusion with the DynaNail, despite using a conservative CT-based method of fusion assessment. The authors conclude that the DynaNail is “safe and effective in generating axial compression across both tibiotalar and subtalar joints in TTC arthrodesis.” Similar to the Duke study, the patient cohort included many co-morbidities and complex pathologies including diabetes, Charcot neuroarthropathy, tobacco use, revision of prior failed fusions, and use of bulk structural allograft to fill large bony defects. These conditions have all been reported in previous literature to increase the risk for non-union with fusion rates as low as 50 percent3,4 in certain patient populations, underscoring the significance of the fusion results shown in the two studies here. “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,” said MedShape Director of Clinical Research Kenneth Dupont, Ph.D. “Combined with an already sizeable amount of peer-reviewed, published data, these studies indicate 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 is a nail’ no longer applies when DynaNail is available as a part of a surgeon’s tool kit.” Launched in 2013, the DynaNail represents a breakthrough in joint fusion technology with its ability to maintain active compression post-surgery during bone healing as well as offer immediate dynamization to prevent stress shielding.5,6 The JFAS and other recent clinical studies7,8 demonstrate how the recovery of the DynaNail’s internal NiTiNOL Element can be radiographically tracked post-surgery, consequently verifying that compression can be maintained for up to 6 mm of the NiTiNOL Element’s recovery capacity. The DynaNail is available in multiple diameter and length offerings and is accompanied by a single instrument tray including the robust DynaFrame CF™ Deployment System. For more information on DynaNail, please visit www.medshape.com/our-products/dynanail.html. About MedShape, Inc.: MedShape, Inc. is a privately held medical device company working to develop and commercialize a portfolio 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. For more information, visit www.medshape.com.
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