Skin and mucosa penetrating bone anchored implants are widely used in orthopaedic, oral and maxillofacial surgery. The number of intra-oral implants alone inserted annually exceeds one million world-wide. The success rate of such implants is dependent on many factors but has been shown to be as high as 90% in experienced centres. When placed in bone of poor quality of grafted or irradiated tissues the success decreases to approximately 70%. Currently there is no satisfactory method to assess the suitability of bone for implant placement or to monitor healing and the performance of implants in function. Implant failure is commonly asymptomatic and the first evidence is increasing implant mobility at which point the component has to be removed. A novel technique has recently been developed which entails attaching a small transducer to an impiant at placement or at any subsequent stage. A low amplitude electrical signal causes the transducer to vibrate in the range typically 5-1 5kHz. The response of the transducer is recorded and at a certain frequency the transducer resonates. It has been shown in-vitro and in-vivo that this frequency is a function of the stiffness of the implant-tissue interface and the level of the marginal bone around the implant. It has also been shown that the transducer has a directional component and can be used to map the interface. In-vitro and in-vivo research and development has been undertaken which has led to the production of dedicated electronic instrumentation that may be used safely with patients and transducers which may be used clinically and will withstand autociaving. This work has reflected the close collaboration between technology users and producers; clinicians, mechanical engineers with expertise in dynamics and industry. It is considered appropriate that the viability of resonance frequency analysis as a clinical diagnostic tool is assessed under realistic operating conditions. In order to do this it is proposed that sufficient prototypes are built to enable clinical studies to be undertaken in four European centres, each with specialist expertise in certain areas. In addition the technique will be demonstrated to clinicians visiting these centres and attending courses. Demonstrations will also be given to public and regulatory bodies. The aim of the project is to establish the viability of the technique and gather sufficient data to enable the method to be fully exploited. Significant interest has already been shown in commercial development of the method and appropriate measures will be taken to ensure that technology transfer is effectively undertaken. Resonance frequency analysis is a noninvasive test method which has considerable potential as a diagnostic technique. Not only could it result in stronger competitiveness in European industry but it will also improve the quality of life of patients reducing the number of radiographs taken and possibly the number of suroical procedures.
Funding SchemeCSC - Cost-sharing contracts
402 26 Göteborg