MedShape and CurveBeam Initiate Joint Prospective Clinical Study

By Julie A. Vetalice

MedShape and CurveBeam Initiate Joint Prospective Clinical Study

MedShape and CurveBeam commenced a prospective clinical study, "Tibiotalocalcaneal Arthrodesis Utilizing a Sustained Dynamic Compression Intramedullary Nail with Longitudinal Weight-Bearing CT Analysis." The study will evaluate the efficacy of MedShape's DynaNail® TTC Fusion System using CurveBeam's LineUP™ weight-bearing CT (WBCT) system.

DynaNail's internal nickel titanium (NiTiNOL) Compressive Element actively is designed to adapt to bone resorption and other changes during bone healing. This 45-patient seeks to correlate the NiTiNOL Element recovery and three-dimensional fusion assessment with a patient's functional improvement.

Using CurveBeam's low dose LineUP WBCT System, CT scans will be obtained at five post-operative intervals (up to 12 months), allowing for more longitudinal temporal tracking of the fusion process than would be permitted with traditional CT systems. The weight-bearing CT protocol also allows for a more accurate three-dimensional reconstruction of the fusion site that can then be compared with two-dimensional radiographs.

Earlier this year, MedShape was acquired by DJO as part of that company's strategic entry into the estimated $1 billion foot and ankle market.

Product Labels: Trauma Ankle/Foot/Toe, Lower Extremity

Tags: Trial/Study