Science and Clinical Experience Total Talus Replacement (TTR)
The total talus is in every foot and ankle discussion on challenging ankle problems. This innovative technology, approved under a Humanitarian Device Exemption (HDE), has had a welcome reception. While the tibiotalocalcaneal fusions are not that great, the concept of talus replacement is attractive. It’s time for a well-designed trial on TTR and Restor3d is leading the way.
The details
In the study "Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)," 50 subjects will receive total talus replacement. The main goal is to assess both the safety and probable benefit of the procedure. Patient-reported outcomes and pain scales will be measured using validated scoring systems. The safety endpoint is defined by the absence of device-related SAE and subsequent secondary surgical intervention (SSSI) on the affected joints at five years. Click herefor full details.
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