Final Report Summary - FRACFIX (Elimination of secondary surgery for removal of internal fixations of fractured bones)
Executive Summary:
The FRACFIX Consortium consists of six companies, assembled to develop a novel type of bone fixator that could be removed easily from the body when healing was complete. This will eliminate the need for major secondary surgery. Three research organisations developed a bone fixator system for the consortium that could be softened within the body. The fixators can also be reshaped during the healing process to reduce pain and discomfort during the healing process.
In a two year project, two types of fixator were selected as manufacturing prototypes. Mechanical testing confirmed that they had the desired characteristics to be used within the body as support during the bone healing process. A system was developed to soften the fixators remotely. Both the fixators and the softening system were developed to prototype stage so that both could be demonstrated. Basic biocompatibility trials have been promising but will have to be confirmed with further testing.
Tests with prototypes have confirmed the practicality of using the FRACFIX system to either remove fixators was a simple out-patient procedure or reshape them to reduce pain and discomfort during the healing process. The latter application has been targeted as the immediate next step for the consortium in commercializing the know-how, materials and technology developed within this project.
Project context and objectives:
The main objective of the FRACFIX project was to develop a novel fixator that can be removed from the body after the fractured bones have healed, under local anesthetic. The consortium consisted of six companies:
Indosynt (Norway, expertise in the growth of bones and orthopaedic surgery), Plastic & Rubber Precision (PRP) (UK, skills in moulding), Wells plastics (UK, formulator of polymers), Motor Generator (MG) Electric (UK, medical devices), Foretec (France, endoscopes), MEVI (Czech Republic, manufacturer of electronic devices). The research and development work was carried out for these six small European companies by Nor-Tek (Norway, project coordination, management and polymer expertise), Oslo university hospital (Norway, testing of biocompatibility) and the Fraunhofer institute for manufacturing engineering and automation (Germany, medical equipment).
This was a two year project, to:
- Develop knowledge about polymers to be used in the fixator
- Develop suitable fixator systems
- Develop and Extraction System
- Validate the technology and integrate the various components
- Perform basic tests to confirm biocompatibility of the fixator design
The other major activities were on project management, dissemination and managing the consortium Project Results:
The main results were:
- Polymer types were selected, with suitable reinforcement and inserts to enable the fixators to be softened when desired.
- Two types of fixator design were developed, which can be used to treat a variety of fracture types
- An electronic device was developed that can be used to soften the fixators from outside the body, so that they can either be removed or reshaped.
- The fixators were shown to have the desired physical properties to be fit for purpose. The electronic device was shown to soften the fixators remotely when desired.
- Basic biocompatibility trials have been promising but will have to be confirmed with further testing
In terms of exploitation of this foreground knowledge, the fixator designs, materials and manufacturing technologies are used to make composite bone fixators that can be removed or modified using an external electronic device.
This foreground knowledge can be exploited by Indosynt, who will integrate the total solution and market the fixators.
Wells and PRP will form the supply chain to make the fixators.
Indosynt entered the project holding this basic patent (material for surgical use in traumatology, US2009265016) to cover the design and system and have taken out fresh claims to cover modification of the fixator and leaving it in the body during the healing process. Further development and demonstration work is necessary to obtain biocompatibility data sufficient to convince regulators, healthcare professionals and potential distributors to use the FRACFIX solution. Indosynt will gain from marketing the total FRACFIX solution (or licensing it to ma major distributor), while Wells and PRP will gain by making the fixators
The electronic device for softening the composite bone fixator in situ (i.e. inside the body) can be exploited by Mevi, who will make the device in any subsequent supply chain. There is no patent protection involved in this device and the IPR is represented by in house knowledge (designs, circuit diagrams etc). Further development and demonstration work is necessary to type-approve and 'ruggedize' the device before it can be used in a healthcare setting. Mevi will gain from selling the device, either directly or as part of a total package. Motor Generator (MG) Electric's role would be to supply a cooling system.
Potential Impact:
Recovering from breaks to bones is both an expensive and a painful process. Every year, 140,000 patients across the EU have surgery for removing internal bone implants each year. These operations cost around 1,500 per patient. There are major complications during 18.1% of these procedures and minor complications in 13.5% of all cases. Some complications may even lead to the death of the patient, due their general condition (they are often elderly), medical mishaps and the effects of anaesthetics.
The project addressed the two main problems with the current range of fixators:
- Most standard metal internal fixators need to be removed after the fracture has healed. This needs open surgery under full anaesthesia, which is both costly and potentially dangerous
- Bioresorbable polymers can eliminate the need for secondary surgery. However, they do not have sufficient strength and start to be absorbed by the body before healing has been completed. They are particularly unsuited for large bone fractures (such as the femur).
In this project, the FRACFIX Consortium has demonstrated the basic technologies to commercialise new types of bone fixator to the market. One type can be removed easily from the body when healing was complete, eliminating the need for major secondary surgery. Other types can be reshaped during the healing process to reduce pain and discomfort during the healing process. The latter application has been targeted as the immediate next step for the consortium in commercializing the know-how, materials and technology developed within this project.
If the consortium are able to commercialise their developments successfully (around 2015?), there will be a new range of bone fixators available to doctors and patients. This will reduce risk to the patients, reducing operation and recovery times while saving around 60% of the costs of secondary surgery. Internal fixation devices in orthopaedic surgery represent an estimated 980 million market in the EU. This is a market dominated at present by large US medical equipment companies, although lower cost products from the Far East are gaining in market share.
List of websites:
The project website (http://www.fracfix.com(opens in new window)) has remained unchanged throughout the 33 months of this project. The site was set up by Nor-Tek and it gives on purpose only the most basic of information on the project. The website will be retained in the post-project period but there are no plans to expand it until at least 2014.
The FRACFIX Consortium consists of six companies, assembled to develop a novel type of bone fixator that could be removed easily from the body when healing was complete. This will eliminate the need for major secondary surgery. Three research organisations developed a bone fixator system for the consortium that could be softened within the body. The fixators can also be reshaped during the healing process to reduce pain and discomfort during the healing process.
In a two year project, two types of fixator were selected as manufacturing prototypes. Mechanical testing confirmed that they had the desired characteristics to be used within the body as support during the bone healing process. A system was developed to soften the fixators remotely. Both the fixators and the softening system were developed to prototype stage so that both could be demonstrated. Basic biocompatibility trials have been promising but will have to be confirmed with further testing.
Tests with prototypes have confirmed the practicality of using the FRACFIX system to either remove fixators was a simple out-patient procedure or reshape them to reduce pain and discomfort during the healing process. The latter application has been targeted as the immediate next step for the consortium in commercializing the know-how, materials and technology developed within this project.
Project context and objectives:
The main objective of the FRACFIX project was to develop a novel fixator that can be removed from the body after the fractured bones have healed, under local anesthetic. The consortium consisted of six companies:
Indosynt (Norway, expertise in the growth of bones and orthopaedic surgery), Plastic & Rubber Precision (PRP) (UK, skills in moulding), Wells plastics (UK, formulator of polymers), Motor Generator (MG) Electric (UK, medical devices), Foretec (France, endoscopes), MEVI (Czech Republic, manufacturer of electronic devices). The research and development work was carried out for these six small European companies by Nor-Tek (Norway, project coordination, management and polymer expertise), Oslo university hospital (Norway, testing of biocompatibility) and the Fraunhofer institute for manufacturing engineering and automation (Germany, medical equipment).
This was a two year project, to:
- Develop knowledge about polymers to be used in the fixator
- Develop suitable fixator systems
- Develop and Extraction System
- Validate the technology and integrate the various components
- Perform basic tests to confirm biocompatibility of the fixator design
The other major activities were on project management, dissemination and managing the consortium Project Results:
The main results were:
- Polymer types were selected, with suitable reinforcement and inserts to enable the fixators to be softened when desired.
- Two types of fixator design were developed, which can be used to treat a variety of fracture types
- An electronic device was developed that can be used to soften the fixators from outside the body, so that they can either be removed or reshaped.
- The fixators were shown to have the desired physical properties to be fit for purpose. The electronic device was shown to soften the fixators remotely when desired.
- Basic biocompatibility trials have been promising but will have to be confirmed with further testing
In terms of exploitation of this foreground knowledge, the fixator designs, materials and manufacturing technologies are used to make composite bone fixators that can be removed or modified using an external electronic device.
This foreground knowledge can be exploited by Indosynt, who will integrate the total solution and market the fixators.
Wells and PRP will form the supply chain to make the fixators.
Indosynt entered the project holding this basic patent (material for surgical use in traumatology, US2009265016) to cover the design and system and have taken out fresh claims to cover modification of the fixator and leaving it in the body during the healing process. Further development and demonstration work is necessary to obtain biocompatibility data sufficient to convince regulators, healthcare professionals and potential distributors to use the FRACFIX solution. Indosynt will gain from marketing the total FRACFIX solution (or licensing it to ma major distributor), while Wells and PRP will gain by making the fixators
The electronic device for softening the composite bone fixator in situ (i.e. inside the body) can be exploited by Mevi, who will make the device in any subsequent supply chain. There is no patent protection involved in this device and the IPR is represented by in house knowledge (designs, circuit diagrams etc). Further development and demonstration work is necessary to type-approve and 'ruggedize' the device before it can be used in a healthcare setting. Mevi will gain from selling the device, either directly or as part of a total package. Motor Generator (MG) Electric's role would be to supply a cooling system.
Potential Impact:
Recovering from breaks to bones is both an expensive and a painful process. Every year, 140,000 patients across the EU have surgery for removing internal bone implants each year. These operations cost around 1,500 per patient. There are major complications during 18.1% of these procedures and minor complications in 13.5% of all cases. Some complications may even lead to the death of the patient, due their general condition (they are often elderly), medical mishaps and the effects of anaesthetics.
The project addressed the two main problems with the current range of fixators:
- Most standard metal internal fixators need to be removed after the fracture has healed. This needs open surgery under full anaesthesia, which is both costly and potentially dangerous
- Bioresorbable polymers can eliminate the need for secondary surgery. However, they do not have sufficient strength and start to be absorbed by the body before healing has been completed. They are particularly unsuited for large bone fractures (such as the femur).
In this project, the FRACFIX Consortium has demonstrated the basic technologies to commercialise new types of bone fixator to the market. One type can be removed easily from the body when healing was complete, eliminating the need for major secondary surgery. Other types can be reshaped during the healing process to reduce pain and discomfort during the healing process. The latter application has been targeted as the immediate next step for the consortium in commercializing the know-how, materials and technology developed within this project.
If the consortium are able to commercialise their developments successfully (around 2015?), there will be a new range of bone fixators available to doctors and patients. This will reduce risk to the patients, reducing operation and recovery times while saving around 60% of the costs of secondary surgery. Internal fixation devices in orthopaedic surgery represent an estimated 980 million market in the EU. This is a market dominated at present by large US medical equipment companies, although lower cost products from the Far East are gaining in market share.
List of websites:
The project website (http://www.fracfix.com(opens in new window)) has remained unchanged throughout the 33 months of this project. The site was set up by Nor-Tek and it gives on purpose only the most basic of information on the project. The website will be retained in the post-project period but there are no plans to expand it until at least 2014.