Design and integration of an instrumented knee prosthesis

Abstract

Total knee arthroplasty is nowadays one of the most important orthopedic surgery. It consists of a procedure in which parts of the knee are replaced by a prosthesis. The largest indication for total knee arthroplasty is osteoarthritis, a knee disease that can cause the cartilage of the femur and tibia to wear away, so that the bones rub together with use. The major risk factors for osteoarthritis are aging and obesity. Both the life expectancy and the obesity rate are increasing in the developed countries, thus the number of estimated total knee arthroplasties is growing over the years. Although over one million of prosthetic joints are implanted every year in the developed countries, none of them contains sensors to help the orthopedic surgeons in improving the precision of the replacement surgery. The goal of this study is to design an electronic system to be embedded inside a total knee prosthesis, in order to measure the force applied to it and its kinematics. Providing the orthopedic surgeons with quantitative data on the biomechanics of the prosthetic knee can help them in improving the implant precision and, as a consequence, could reduce the risk of an early revision surgery. In the frame of this thesis, we worked with the F.I.R.S.T. prosthesis by Symbios Orthopedie SA, that was instrumented with sensors and electronics to measure, process and transmit force and kinematics data to an external reader. The constraints in the design have been established by the medical doctors and the prosthesis manufacturer and the technical solutions adopted are presented. In order to simplify a future approval for human tests, we decided to keep the shape of the knee artificial joint. To achieve that, we put all the sensors and the electronics inside the middle part of the prosthesis, constituted of a polyethylene insert located between the metallic parts of the artificial joint and whose function is to reduce the rubbing. An original encapsulation was designed to guarantee the bio-compatibility of the instrumented prosthesis and to avoid a potentially dangerous contact between the electronics and the human body. This should be ensured even in case of extreme wearing of the polyethylene insert, that can occur some years after the prosthesis implant and is one of the main indications for a revision surgery. The sensors were tested by using mechanical simulators of the knee joint and validated by means of reference sensors. Different demonstrators have been designed, from the first, with only the sensors located inside the prosthesis and all the electronics fabricated in a large-scale outside of it, to the last miniaturized versions, that can be entirely embedded inside the prosthesis. Moreover, an autonomous sensor for balancing the ligaments tension during the knee replacement surgery was designed, fabricated and tested. Such a device could be an important help for the medical doctors during the surgery to improve the precision of the implant and, being not-implantable, could easily obtain an approval for human clinical trials.