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Big Data driven personalized knee replacement

Periodic Reporting for period 2 - BD-KNEE (Big Data driven personalized knee replacement)

Reporting period: 2020-04-01 to 2021-03-31

Total Knee Replacement (TKR), is one of the most commonly performed orthopaedic procedures, reaching >4M cases per year.
Even though TRK nowadays is a routine procedure, and numbers have doubled in the last 15 years, still 20 to 30% of patients are dissatisfied with their results and 6.2% of them will require a TKR revision in the following 10-years.
Furthermore, the lack of systematic follow-ups and rehabilitation monitoring impacts on the comprehension on long-term TKR results.
Although the orthopaedic market is a continuously growing market, the biomedical “Total Knee Replacement” (TKR) industry has been static and stationary for many years, regarding material evolution, design, surgical procedures and surgical recovery. Current knee implants are designed for any patient without considering the specific patient’s anatomy. As a result, many implants are larger or smaller than the patient knee, which at the end of the day generates lots of problems after the surgery and affects the patient quality of life for years.

Currently, more than 242 M people in the world suffer from Osteoarthritis (OA), a degenerative joint disease that occurs when the cartilage or cushion between joints breaks down leading to pain, stiffness, and swelling.
Even though OA can affect any joint, it happens most often in knees and hips . Thus, nowadays knee OA alone accounts for more than 80% of the disease’s total burden, and 50% of OA cases.
While at short-term, the disease may result in instability, stiffness or imbalance; at medium & longterm, when OA knee proceeds, it triggers the degeneration of articulations. In these cases, the most effective intervention is a knee replacement to
reduce pain and restore function and mobility.

BD-KNEE is a “patient specific” holistic solution that provides personalized knee replacement (commercially known as YOURKNEE) and surgery recovery follow-up through:
- The analysis of the patient`s anatomy, the implant design and surgery simulation based on patient's anatomy data, thanks to BD-KNEE ICT platform & software
- The production of a patient specific implant by a novel 3D printing technology (EBM-AM)
- The delivery of specific surgical tools and computer assisted surgical tools (Smart Perseus by Orthokey) for a personalized surgery, through three surgery devices connected to the ICT platform & software
- A knee smart-sensor band to monitor the surgery recovery and patient rehabilitation

1. Surgical Time Reduction (10 minutes during set-up in the operating room, valued at €300 (€30/min), plus 10 minutes during surgery, valued at € 600 (€60/min)).
2. Blood Loss Reduction, saving up to €100 for each patient per transfusion.
3. Infection Risk Reduction, based on time saving of >10%
4. Faster Rehabilitation due to personalized implant and surgery recovery monitoring
5. Early detection of abnormalities through monitoring during recovery and potentially early intervention
6. Cost Saving for hospitals estimated in €2,200/patient (from avoiding costs associated with complications,
infection rate and hospital stay).
7. Reduction of implant-related errors and waste in TKR (from 5% to 0%)
❖ During the first year of the BD-KNEE project the following objectives have been achieved:

1. Optimization of the 3D implant manufacturing process, based on EBM-additive manufacturing (EBM-AM) technology, using materials composed of CoCr alloy.
2. Optimization of the manufacturing process through SLS (Selective Laser Sintering, an AM technology) for the 4 in 1 patient specific jig (medical grade nylon/plastic), patient specific surgery tool.
3. Finalization of the implant design, expanding the range of our current 31 basic sizes prototypes (femoral, L/R) to 7.500+ sizes prototypes (femoral, L/R) using statistical shape analysis.
4. Refinement of the software modules (the product life management software, the medical grade patient database, the cloud ERP system, the computer-assisted surgery software (SmartPerseus APP) and the preoperative
software program Enhatch).
5. Refinement of sensor knee band.
6. Integration of software modules into the ICT-platform together with a CAD tool.
7. Integration of software for surgery support (Smart Perseus, and the 4 in 1) into the ICT-platform.
8. Completion of the web portal ICT-platform for a personalized TKR.

❖ During the second year of the project following objectives have been achieved:
9. Validation of the integrated system and optimized implants in an operational environment
10. CE-Mark certification and FDA510K technical folder preparation for BD-Knee medical devices
11. Protection of Intellectual Property (IP).
12. Refinement of the marketing plan (price, selling arguments, target markets).
13. Achievement of commercial agreements among a target panel of 16 potential partners.
14. Dissemination of BD-Knee benefits through general media, social media webpage, and direct contacting with > 20 surgeons.
15. Preparation of commercial launch to enter into the market by 2021.
❖ BD-KNEE system innovation
The BD-KNEE is a “patient specific” system that provides innovative knee replacement devices, matching ICT with 3D printing new production technologies and smart surgical tools which reduce patient pain, speeding up the recovery with a competitive price.

❖ BD-KNEE impact on societal challenge #1 Health, demographic change and wellbeing
OA is currently one of the 10 most disabling diseases in developed countries and will rise exponentially in the future years affecting the health and the wellbeing of population.
BD-KNEE anticipates to the future and raising need for TKR. Due to the expected population aging, it is estimated that by 2050, 20% of the population will be over 60. Age is the strongest predictor of OA development, which affect 80% of over 65 years’ population. If OA progress, in many cases, the most effective intervention is a knee replacement to reduce pain and restore function and mobility. In contrast to current alternatives, BDKNEE will enable a reliable TKR thanks to the personalized implants and the rehabilitation monitoring. Due to the user friendly interface of the surgical tools, the pre-configuration of the surgery, the “Patient-Specific” concept that brings in the OR just the needed material, and the easiness of the 2 steps surgical technique.

❖ BD-KNEE increases the consortium competitiveness
BD-KNEE will make possible to bring two European companies and a European JV to the front row of the orthopaedic implants and surgery systems field, currently dominated by US companies.
Thanks to BD-KNEE FTI, the companies of the consortium will gain relevance in the field and expects to increase their revenues from 20% up to 80%, in the case of REJOINT.

❖ BD-KNEE environmental impact
EBM-AM technology major mainstays is its environmental friendliness through low material wastes, minimal tooling and the possibility to produce different parts in each batch, reducing logistic processes.
The manufacturing process used by BD-KNEE significantly cuts on resources/energy consumption and pollutant emissions from upstream and during manufacturing, assembly and at the end of the lifecycle.
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