Personalised Surgical Process for Joint Replacements
JOINT STATEMENT OF DEMAND
Corporació Sanitària Parc Taulí (CSPT) has identified an unmet need for solutions to enable the personalisation of the joint replacement surgical pathway.
This joint statement of demand describes the current situation and its limitations, why innovation is needed, and the outcomes required of the new solution.
In order to demonstrate a credible market demand for a solution that can deliver these outcomes, we have been reaching out to other hospitals that may have a similar need and may, in the future, be interested in buying such a solution and /or collaborating in this initiative.
We are continue to reach out to other healthcare providers who may be interested in new and innovative solutions to improve the joint replacement pathway.
We, therefore, invite you to read this statement of demand and provide your feedback via a short survey.
We hope you find this information useful and are happy to take part in our Survey, as well as sharing this information with others you think might be interested in finding out more.
Organisations that support this initiative and share this unmet need
- Biodonostia Health Research Institute (Spain)
- Vall d’Hebron Barcelona Hospital Campus (Spain)
- Hospital Clínic de Barcelona (Spain)
- Vilnius University Hospital Santaros Klinikos (Lithuania)
- Sant Joan de Deu Hospital (Spain)
- Italian Society of Architecture and Engineering in Health (Italy)
Our Aim
Our aim is the personalisation of joint replacement, shifting from a ‘best fit’ scenario to tailor-made joints for each patient.
Personalised medicine is becoming more and more common in clinical practice. It has been proven to provide both patients and physicians with considerable benefits, such as increased satisfaction, as well as the possibility of enhancing the efficiency of the health system, reducing costs and avoiding post-operative complications. [1]
Why innovation is needed
A joint replacement is a surgical procedure in which parts of a damaged joint are removed and replaced with a metal, plastic, or ceramic prosthesis, which is designed to replicate the movement of a healthy joint.
In 2019, 595 joint replacements were performed in CSPT, with 120,000 in Spain and more than 3 million across Europe. Moreover, as the general population ages, the number of joint replacements is expected to increase every year.
Success factors in joint replacement
Joint replacement is a complex operation and the most important determining factors for success are the fit of the implant to the patient’s body, and the suitability of the implant for the specific characteristics of the patient including gender, height, weight, and age.
In this scenario, the surgeon has to make important surgical choices that have consequences in terms of patient outcomes, cost, and use of resources during the operation based on professional judgement and experience. These ‘in situ’ choices include the material to be used, the optimal positioning and the size of the implant.
It is essential for the surgical outcome that the surgeon has all the possible options at their disposal in order to select the best possible fit for the patient during the operation.Alex Berenguer, MD, PhD Orthopedic Hand Surgeon, Hospital Universitari Parc Taulì Sabadell
Consequently, the surgeon needs to have a sufficient range of trial implants and instrumentation available to them during the operation, and each of these needs to be selected and sterilised in advance of the surgery.
An additional complication for the surgical team is that the most appropriate size might not be available. The manufacture of implants and instrumentation is based on a supplier’s prediction of how many of each size will be needed in any given year. As a consequence, the supply of minority sizes can become limited. In Spain, this problem is exacerbated by the population’s characteristics meaning that a greater number of minority sizes are required than in other countries such as the US. [2]
Another important aspect of the surgical process is the pre-operative assessment of the patient to enable the surgeon to narrow down the number of trial implants that have to be prepared. Currently this includes a CT scan, which is limited to the joint in question due to concerns about excessive radiation exposure. Increased precision and interpretation of the measurement, and moreover a whole-body comprehensive biomechanical and medical assessment scan would enable optimisation of the design of a patient-specific solution.
We find that in some cases the positioning and fit of new joints are less than ideal, which may cause post-operative and functional complications, resulting in periodic revisions and in some cases revision surgeries. With a tailor-made solution, this issue would be eliminated and now technology can make this possible.Ferran Fillat, PhD Orthopedic Surgeon and 3D Surgical Planner Specialist, Hospital Universitari Parc Taulì Sabadell
Tailor-made solutions would remove the resource-intensive preparation for surgery and optimise the joint replacement process. By ‘tailor-made’ we mean bespoke implants and patient-specific instrumentation enabled by precision measurement taking into account variables such as height, weight, age, derived during the pre-operative examination process that can be processed to enable on-demand, personalised manufacture of implants and patientspecific instrumentation.
The traceability of the whole surgical process from the point when the responsible surgeon indicates a surgery until it is carried out is necessary to monitor the whole process. This is essential for compliance with European regulations on custom-made medical devices. [3]
The requirement
The unmet need that we have identified can be summarised as follows.
Personalised surgical process for joint replacements, incorporating:
- The design and on-demand manufacture of tailor-made joint replacements and patient specific instrumentation
- Pre-operative precision measurement incorporating whole body assessment to optimise the personalised biomechanical performance
- The monitoring and full traceability of both the manufacturing and surgical process
The solution should:
- Deliver demonstrable clinical, cost and resource benefits
- Have the potential to be applied to other areas of elective surgery
- Meet all necessary standards in relation to quality, approvals, ethics and data protection, inter-operability etc.
What can you do next?
Thank you for taking the time to read this Statement of Demand. CSPT is keen to identify and engage with other surgeons, hospitals, and healthcare providers that have the same or similar needs before we start communicating with potential solution providers. At this stage, we have the flexibility to adapt the Statement of Demand to include particular needs that would increase its relevance for other interested healthcare providers.
Demonstrating that there is a wider potential market will better encourage potential suppliers to invest in developing innovative solutions that meet the unmet needs identified.
Your voice is vital to encourage suppliers to innovate to provide solutions. If you also believe that this is an unresolved issue or unmet need or would like to provide feedback, please take our short survey.
REFERENCES
-
Tack P, Victor J, Gemmel P, Annemans L. 3D-printing techniques in a medical setting: A systematic literature review. Biomed Eng Online. 2016;15(1):1–21
-
Rosales-Rosales L, Rosales-Varo AP, García-Espona MA, Roda-Murillo O, Montesinos I, Hernandez-Cortés P. Anthropometrical study of the human glenoid in a normal Spanish population. Rev Española Cirugía Ortopédica y Traumatol (English Ed [Internet]. 2019 Sep;63(5):327–35. Available from: https://linkingelsevier.com/retrieve/pii/S198888561930046X
-
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EE [Internet]. 2017 [cited 2020 May 6]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
About the buyer
This Statement of Demand has been developed by the following partnership in the context of the EcoQUIP+ project:
Corporació Sanitària Parc Taulí (CSPT) is a healthcare centre, which provides high-quality health care to a population of 420.000 inhabitants in the eastern Catalan region of Spain. As an indicator of its activity, CSPT is equipped with a total of 744 beds, including Intensive Care Units (ICU) beds, rehabilitative care beds and long-term care beds.
Fundació Parc Taulí (FPT) is an organisation that supports biomedical teaching, training, and research in collaboration with CSPT. FPT provides researchers with facilities for basic research, assistance in search of funds for scientific and medical research.
Agència de Qualitat i Avaluació Sanitàries de Catalunya (Agency for Health Quality and Assessment of Catalonia, AQuAS) is a public entity of the Catalan Department of Health whose mission is to generate scientific and relevant knowledge to contribute to the improvement of the quality, safety, and sustainability of the healthcare system.
