ConforMIS | iTotal G2 Knee Replacement | Which Medical Device
From Which Medical Device
The iTotal (R) knee replacement from ConforMIS is a customised knee replacement system in which CT data are used to manufacture a patient-specific implant. Patient-specific jigs (the iJig (R) instrumentation) are used in implantation as part of the system. This customised approach can improve the fit of the prosthesis, reduce under- and over-hang and reduces the inventory required. The implants are manufactured in cobalt-chromium-molybdenum using direct digital manufacturing and standard metal-working techniques.
For clinical trials of the iTotal knee click here.
The manufacturer has supplied the following information:
The iTotal G2 from ConforMIS is a knee replacement system consisting of customised instrumentation and implants. iFit image-to-implant technology converts a CT-scan of a patient’s knee to a 3D model which is used to design a patient-specific implant manufactured to mimic the exact shape and contours of the patient’s natural knee. In traditional knee replacements, implant underhang or overhang as well as tibial malrotation are leading causes of residual post-operative pain.
ConforMIS’ personalised approach eliminates these sizing compromises and allows the surgeon to achieve proper rotational alignment without sacrificing implant coverage. The iTotal implants are also designed to match the patient’s condylar geometry while also preserving their medial and lateral joint line, which provides each patient with the potential for a more natural feeling knee.
CT-scan data is also used to design pre-navigated surgical instrumentation unique to each patient. This simplifies the surgical procedure and allows for more precise alignment and cuts. The typical knee replacement procedure requires 8-12 trays that must be set up, broken down, and sterilized. With ConforMIS, both the implant and instrumentation come in one pre-sterilized, disposable kit along with one other tray of re-usable instrumentation. This reduces the risk of infection as well as time and resources spent in the operating room.
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