Traumatic Amputation of Lower Extremity Clinical Trial
Official title:
Direct Skeletal Fixation of Prosthetic Limbs Following Trans- Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAP)
Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).
The core ITAP™ design comprises of three discrete sections, the proximal section, which is
the intramedullary stem secured into the medullary canal, the soft tissue integration flange
and the transcutaneous component that passes through the skin. The device has been designed
to be surgically implanted in a one stage procedure. In greater detail:
Intra-medullary stem - this component is designed to match the natural shape of the canal and
is designed using the same principles established and used for the fixation of massive
endo-prosthetic replacements. In certain cases a hydroxyapatite ceramic (CaPO4) coating is
used, providing enhanced uncemented fixation. In other cases, depending on the geometry of
the intramedullary canal, the stem can be fixed in place using acrylic bone cement.
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