MedShape, Atlanta, announced the initiation of a new prospective clinical study with the Orthopaedic Foot & Ankle Center jointly with CurveBeam. The study, titled “Tibiotalocalcaneal Arthrodesis Utilizing a Sustained Dynamic Compression Intramedullary Nail with Longitudinal Weight-Bearing CT Analysis” will evaluate the efficacy of MedShape’s DynaNail TTC Fusion System using CurveBeam’s LineUP WBCT system.
DynaNail is the only intramedullary nail that provides sustained dynamic compression. Its patented internal nickel-titanium (Nitinol) compressive element actively adapts to bone resorption and other changes during bone healing, a feature that can be tracked post-operatively on radiographs. While MedShape has several ongoing clinical trials evaluating the efficacy of a sustained dynamic compression nail, this 45-patient study marks the first aimed at correlating the Nitinol element recovery and three-dimensional fusion assessment with a patient’s functional improvement.
“There is a gap in the clinical literature around the spatiotemporal development of the fusion mass and the factors that affect this process,” said Ken Dupont, Ph.D. and MedShape director of clinical research. “With this study, we will be able to assess when and where specifically bone growth occurs and compare this growth pattern amongst different patient groups with various challenging co-morbidities. We already know that sustained dynamic compression can lead to improved fusion results, but this new data could help optimize the compression performance in future devices.”
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