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Exploitable results
The word anchorage refers, in the biomedical field, to the old dream of the connection between a living organism and prosthesis. The history of joint replacement is governed by the problem of the fixation of the implants. First indicated for older patients only, the increasing success of the procedure conducted to an enlargement of the indications to younger patients. Joint replacement is now a routine procedure bringing a solution to public health problems. One crucial problem is to estimate the mechanical and biological quality of the anchorage.
Loosening is one of the major problems of joint replacement. It has a server repercussion on the comfort of the patient, as its painful. The other major problem is a consequence of loosening: when it destroys the bone surrounding the implant, by direct mechanical action and cellular activity. The actual diagnostic techniques are based on imaging techniques such as X-rays and isotopes. Yet, a crucial analysis reveals that they lack specificity and sensitivity. The STMuLus project envisages the development of a diagnosis protocol using as instrumented total hip prosthesis that allows the quantitative detection of the implant loosening, at an early stage. To cope with the demand of low volume, low power consumption, and biocompatability, an extremely miniaturized micro-system is under development, packaged into a metal ceramic housing, in the implant its self.
We develop a measuring system whereby the patient is submitted to vibration patterns. The response to these vibrations will be monitored by an accelerometer in the prosthesis and transmitted to the outside via a wireless telemetry link. The STIMuLus project merges current Know-how in implant surgery, vibration analysis, advanced electronics and telemetry; a dedicated system is developed:
-An accelerometer located into the implant;
-An implant interface circuit for the accelerometer
-an implant signal processing unit for signal extraction and transmission;
-A system for powering the implanted electronics;
-A telemetry system for data transmission and reception;
-An external unit for the external data transceiver, the implant powering and link to a personal computer.
The unique in situ sensing of the vibration response allows a very accurate analysis and sensitive detection of the implant loosening. Based upon the information contents of the received signal, a diagnosis on the quality of the anchorage of the hip implant becomes possible in a reliable and quantitative manner. We propose to carry the measurements as a regular clinical procedure at the time of the X ray control, or in the case of suspicion. We face the challenge of developing a diagnostic tool, at an acceptable cost, with the following possibilities:
-Increase sensitivity and specificity for loosening;
-Early and objective evaluation of the quality of the anchorage of the prosthesis, early detection of non-painful implant loosening may avoid subsequent bone damage;
-Unnecessary implant-revision market can be avoided if a pain sensation has no other origin than loosening;
-Extension of the implant market with a new generation of smart implants.
Besides, it is also a valuable tool in the evaluation of the new anchorage methods, new surgical techniques or new implant designs, allowing critical and quantitative scrutiny in their development.
Because of its monitoring capabilities, this implant is believed to represent the first of a totally new generation. It may open additional markets for the implant manufactures. The knowledge to develop such a device can only be obtained by combining the expertise of different research institutes because of the high multi disciplinarily involved. Top level expertise over these multiple areas was not existing in one single country but is only available on a European scale. This project represents a complex combination of advanced technologies developed in the European Community, far in advance of the competitive countries. Profit and added value are real concepts for both patients and clinicians.
The STIMuLus project is representative for the European innovative technology and brings to the limit, with an added value, the development of interdisciplinary research fields. -Biomaterials; -Biomechanics; -Microelectronics; -Surgery.
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