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Deposition of encapsulated network of drugs to prevent remedial implant treatment emanting fromdeep bone infection.

Final Report Summary - DENDRITE (Deposition of encapsulated network of drugs to prevent remedial implant treatment emanating from deep bone infection)

Prosthesis implantation of the hip and knee are amongst the most common operations carried out, together with the shoulder and finger prosthesis implantation these account for 1.4 m operations annually across Europe. Although the prosthesis implants and equipment used for their implantation is sterilised postoperative infections occur, resulting in 50 000 cases of deep bone infection and 193 000 cases of superficial infection.

These infections are the result of bacterial contamination during the operation, once removed from the protective packaging, or of contamination of equipment. Deep bone infections often result in the removal of 7% of prosthesis implantations, in severe cases, 9% result in the amputation of the limb. Upon removal of the implantation the patient can be left without an implant for days or months until the infection has been eradicated at which point revisional surgery is performed.

The project's main objective was to develop a surface coating for prosthesis implants such as hip and knee implants that will release drugs for the promotion and early fixation of the implants and for the prevention of infections. This was done through the incorporation of a surface coating that will have both free form hydroxyapatite and polymer encapsulated antibiotic drugs and bone promotion agent that will be released over a time period.

The primary application of the DENDRITE technology was to actually develop an innovative coating that has the potential to reduce post operative infections. This was to be achieved by the timely delivery of antibiotics and bone promotion drugs which we believe has the potential to reduce hospital stays and allow patients to be released early from the early. More over we know that DENDRITE technology can and will be manipulated in the trauma market. It is in this market that the coating technology would provide an indispensable defence against early infections.

It was important for us to develop the DENDRITE technology as it had the potential to allow us to coat dental implants. During the course of the project we have shown that it is possible to coat implant material with a drug-loaded polymer. We held this belief before and during the course of the project. We made every endeavour to reach this as one of our objectives and in doing so it has opened up the possibility of us exploiting the technology further in the dental implant market. The coating of dental implants was seen as only a secondary application however we now believe that we can move forward into the market as well.

The impact of the project was to develop an innovative drug delivery system to deliver gentamycin. This goal was achieved early on in the project. It was vital that we could achieve this in order to build up our confidence and plan for the rest of the project. The medium term impact for the SMEs will be felt over the next 5 years by which time we will have completed any further development work but also any further pre-clinical and clinical studies in order to take the product to market. The DENDRITE partners believe that this will be possible as Finsbury have the capability of achieving this and have partners behind them to achieve further milestones.

The project has carried out an in-depth study on gender, societal and ethical issues. While some gender issues have been reported there were no societal issues. Therefore we have only reported on the societal impact of the project. We have also looked at EC legislation and identified some issues. This report clearly shows that there are limited barriers to the exploitation of the results.

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