Periodic Reporting for period 1 - SINTER (Self-driven INTramedullary bonE Regeneration: Development of a SINTER nail for bone reconstruction)
Période du rapport: 2022-04-01 au 2024-03-31
Problem/Issue Being Addressed
The project addresses the need for an efficient and low-cost solution for bone reconstruction, particularly for patients in low- and middle-income countries (LMICs). Large bone defects resulting from trauma, infection, or tumour resection often require complex surgical procedures and expensive medical devices for reconstruction, which are not readily accessible or affordable in resource-limited settings.
Importance for Society
Providing an affordable and effective bone reconstruction solution has the potential to significantly improve the quality of life for patients in LMICs who suffer from large bone defects. Due to financial constraints, these patients often face limited access to advanced medical treatments, leading to long-term disabilities and reduced mobility. By developing a low-cost intramedullary nail, the project aims to make this life-changing treatment accessible to a broader population, particularly in underserved communities.
Overall Objectives
The project's primary objective is to design, manufacture, and test a novel intramedullary nail that can facilitate the reconstruction of large bone defects through bone transport. The specific objectives include:
1. Developing a distraction mechanism within the nail that can achieve an adjustable rate under physiological forces, allowing for gradual bone regeneration.
2. Optimising the design through computer simulations to ensure the nail can withstand in situ forces and allow for a certain level of patient activity during the distraction process
3. Manufacturing prototypes using conventional machining to explore low-cost production methods suitable for LMICs.
4. Conducting mechanical testing to evaluate the strength and performance of the manufactured nails.
5. Performing an in vivo study on sheep to validate the bone distraction process and reconstruct a large bone defect, serving as proof of concept.
In conclusion, a novel intramedullary nail that can provide an effective and affordable solution for bone reconstruction, particularly benefiting patients in resource-limited settings, was developed by successfully achieving most of these objectives. The fellow has secured further funding to perform the in vivo study and pursue the development of the device.
The project addresses the need for an efficient and low-cost solution for bone reconstruction, particularly for patients in low- and middle-income countries (LMICs). Large bone defects resulting from trauma, infection, or tumour resection often require complex surgical procedures and expensive medical devices for reconstruction, which are not readily accessible or affordable in resource-limited settings.
Importance for Society
Providing an affordable and effective bone reconstruction solution has the potential to significantly improve the quality of life for patients in LMICs who suffer from large bone defects. Due to financial constraints, these patients often face limited access to advanced medical treatments, leading to long-term disabilities and reduced mobility. By developing a low-cost intramedullary nail, the project aims to make this life-changing treatment accessible to a broader population, particularly in underserved communities.
Overall Objectives
The project's primary objective is to design, manufacture, and test a novel intramedullary nail that can facilitate the reconstruction of large bone defects through bone transport. The specific objectives include:
1. Developing a distraction mechanism within the nail that can achieve an adjustable rate under physiological forces, allowing for gradual bone regeneration.
2. Optimising the design through computer simulations to ensure the nail can withstand in situ forces and allow for a certain level of patient activity during the distraction process
3. Manufacturing prototypes using conventional machining to explore low-cost production methods suitable for LMICs.
4. Conducting mechanical testing to evaluate the strength and performance of the manufactured nails.
5. Performing an in vivo study on sheep to validate the bone distraction process and reconstruct a large bone defect, serving as proof of concept.
In conclusion, a novel intramedullary nail that can provide an effective and affordable solution for bone reconstruction, particularly benefiting patients in resource-limited settings, was developed by successfully achieving most of these objectives. The fellow has secured further funding to perform the in vivo study and pursue the development of the device.
The project aimed to develop an intramedullary nail for bone reconstruction over a period of two years. Here is an overview of the main results achieved during this period:
The project successfully developed a new intramedullary nail for bone reconstruction, optimised through computer simulations and validated through mechanical testing. These results could lead to new intellectual property, with the project exploring the best exploitation route (licensing, start-up, or building a business case) in discussion with the Technology Transfer Team at Imperial College London (ICL).
The project's outcomes were disseminated through engagement with stakeholders and outreach activities. This ensured the results' visibility within the scientific community and among potential commercial partners. Furthermore, the project established a foundation for commercialisation, with links to St. Mary’s Hospital and the Royal National Orthopaedic Hospital (RNOH) and support from expert clinicians who can facilitate clinical trials, a crucial step in the commercialisation process.
The project successfully developed a new intramedullary nail for bone reconstruction, optimised through computer simulations and validated through mechanical testing. These results could lead to new intellectual property, with the project exploring the best exploitation route (licensing, start-up, or building a business case) in discussion with the Technology Transfer Team at Imperial College London (ICL).
The project's outcomes were disseminated through engagement with stakeholders and outreach activities. This ensured the results' visibility within the scientific community and among potential commercial partners. Furthermore, the project established a foundation for commercialisation, with links to St. Mary’s Hospital and the Royal National Orthopaedic Hospital (RNOH) and support from expert clinicians who can facilitate clinical trials, a crucial step in the commercialisation process.
The project has made significant advancements beyond the current state of the art in bone reconstruction technology. Developing a novel intramedullary nail represents a notable leap forward from existing bone transport techniques, which typically require daily patient involvement or clinical interventions to manage the distraction process.
Unlike traditional bone transport nails that require manual adjustment, the new nail is designed to achieve the desired distraction rate without any involvement of the patient or physician. This feature significantly simplifies the treatment process.
Socio-economic Impact
The socio-economic implications of this technology are profound, particularly for patients in low- and middle-income countries (LMICs). By reducing the complexity and cost of bone reconstruction:
-Accessibility: The nail's design allows for local manufacturing using simpler, cost-effective techniques, making it more accessible to healthcare systems with limited resources.
-Reduced Healthcare Costs: Simplifying the bone reconstruction process and reducing the need for frequent clinical interventions can lower overall treatment costs. This is crucial in LMICs, where healthcare spending is a significant burden.
Wider Societal Implications
-Improved Patient Outcomes: The nail can improve mobility and quality of life for patients suffering from severe bone injuries by facilitating easier and more reliable bone reconstruction. This contributes to greater societal productivity and reduced disability-related costs.
-Innovation in Medical Technology: The project sets a precedent for future innovations in orthopaedic devices, encouraging further research and development in bone transport technologies.
-Educational and Collaborative Opportunities: The project involves significant knowledge transfer activities, including the training and developing researchers at Imperial College London and collaboration with St. Mary’s Hospital. This aspect fosters a rich educational environment and promotes a culture of innovation and collaboration in medical research.
Unlike traditional bone transport nails that require manual adjustment, the new nail is designed to achieve the desired distraction rate without any involvement of the patient or physician. This feature significantly simplifies the treatment process.
Socio-economic Impact
The socio-economic implications of this technology are profound, particularly for patients in low- and middle-income countries (LMICs). By reducing the complexity and cost of bone reconstruction:
-Accessibility: The nail's design allows for local manufacturing using simpler, cost-effective techniques, making it more accessible to healthcare systems with limited resources.
-Reduced Healthcare Costs: Simplifying the bone reconstruction process and reducing the need for frequent clinical interventions can lower overall treatment costs. This is crucial in LMICs, where healthcare spending is a significant burden.
Wider Societal Implications
-Improved Patient Outcomes: The nail can improve mobility and quality of life for patients suffering from severe bone injuries by facilitating easier and more reliable bone reconstruction. This contributes to greater societal productivity and reduced disability-related costs.
-Innovation in Medical Technology: The project sets a precedent for future innovations in orthopaedic devices, encouraging further research and development in bone transport technologies.
-Educational and Collaborative Opportunities: The project involves significant knowledge transfer activities, including the training and developing researchers at Imperial College London and collaboration with St. Mary’s Hospital. This aspect fosters a rich educational environment and promotes a culture of innovation and collaboration in medical research.