MedShape, CurveBeam Initiate Joint Prospective Clinical Study

MedShape and CurveBeam have announced the initiation of a first it’s kind Joint Prospective Clinical Study: Tibiotalocalcaneal Arthrodesis Utilizing a Sustained Dynamic Compression Intramedullary Nail with Longitudinal Weight-Bearing CT Analysis.

Led by Gregory C. Berlet, MD, and Mark Prissel, DPM, from the Orthopedic Foot and Ankle Center in Worthington OH, the study has some BIG potential implications.

What We Know So Far

Forty-five enrolled patients will undergo tibiotalocalcaneal arthrodesis using Medshape's DynaNail, a technology recently acquired by Colfax under DJO Corporation for its unique proprietary tensioned superelastic nickel-titanium shape memory alloy.

The aim of the prospective study is to assess the nail's sustained compression element with respect to the percent fusion of the ankle and subtalar joint(s) at five temporal points, over 12 months, using CurveBeam's low dose LineUP WBCT System for three-dimensional reconstructions.

Why?

Longitudinal temporal tracking of the fusion process using weight-bearing CT with concurrent assessment of DynaNail's internal nickel titanium (NiTiNOL) Compressive Element may allow for a number of preliminary associations – the most obvious being between the elements position and the percent fusion mass.

This association alone could translate into more patient-centric postoperative protocols for surgeons, affording earlier weight-bearing, and ideally, better outcomes.

Intrigued? Its hard not to be, and more details on the study are sure to be released in the coming months. Stay tuned.