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Evaluation of in-vitro test methods to characterize bone implant materials with special emphasis on biocompatibility and long-term functionality

Objetivo

Assessment of the long-term performance of bone implants in contact with body fluids and tissue materials with special regard to i.) events happening at the phase boundaries on a mo]ecular level, and, ii.) the cellular changes observable in these systems as a function of time leading to the establishment of test methods for biocompatibility and functionality of bone implant applications and of cell culture techniques as powerful tools for these types of investigations, the prediction of the long-term performance of implants in body environments, the verification of concepts of biomedical engineering and both the proposal for a Europan technical recommendation as well as a European data base of bone implant material interactions

Implant materials such as bone implants in orthopaedic and dental practice undergo degradation processes after implantation. This includes the release of certain amounts of dissolved or particulate implant components into the adjacent tissues. Particles, metal corrosion complexes and metal ions are suspected of producing an inflammatory response in the surrounding tissues. On reaching the blood stream or the respiratory system, even a systemic influence of those degradation products may be envisaged. Recent]y published studies have shown that degradation products even in low concentrations, released from commonly utilized materials might, on the basis of their broad spectrum of effects be an important factor in inflammation and inhibition of wound healing processes. Current discussions on implants present evidence that there is a need for a standardized, comparable and reliable testing scheme for materials provided for implantation with respect to their degradation reactions.

Aim of the present project is the establishment of in vitro testing methods to evaluate and predict the long-term performance of bone implant materials and to verify current concepts of biomedical engineering (including bone-bonding materials). Among the chosen materials will be metal alloys and bioactive glasses. Using in vitro conditions to simulate both short- and long-term clinical use, three principal aspects of biocompatibility (biointegration, biodegradation, biodissolution) will be studied. The testing methods will be based on modern techniques of especially cell and molecular biology. This should form the basis of a proposal for future discussions to delineate European standards on the biodegradation of materials and medical devices. Furthermore, data obtained from such testing methods shall act as positive input for the optimization of future implant materials.

Convocatoria de propuestas

Data not available

Régimen de financiación

CSC - Cost-sharing contracts

Coordinador

Umwelt-Campus Birkenfeld Entwicklungs- und Management GmbH.
Aportación de la UE
Sin datos
Dirección
.9935,Am Hasseld, Gabäude
55768 Hoppstädten-Weiersbach
Alemania

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Coste total
Sin datos

Participantes (8)