"International (PSI) Clinical Registry Project”

RAOMED HAS ASSEMBLED AN INTERNATIONAL MULTIDISCIPLINARY TEAM OF PSI EXPERTS AT PRESTIGIOUS ARGENTINE AND EUROPEAN UNIVERSITY MEDICAL CENTERS TO DEVELOP AND IMPLEMENT THE FIRST "INTERNATIONAL PATIENT SPECIFIC IMPLANT (PSI) CLINICAL REGISTRY".

Objective:

The objective of the Project is to establish and implement an International Patient Specific Implant Registry (PSI) to collect outcome, safety, manufacturing and cost data to develop best practice guidelines that will provide a solid foundation for PSI technology to grow successfully and reach its full therapeutic potential.

Background: Large bone defects caused by congenital anomalies, trauma, infection, neoplasm, implant removal and surgical resection constitute a major challenge for patients who suffer with them, the physicians who treat them and the healthcare systems burdened with their high costs.

The incidence of large bone defects is expected to increase greatly due to the advancing age of populations in developed countries, increasing numbers of elderly patients suffering from osteodegenerative diseases, and  an increase in the number of revision surgeries. Treatments for these large bone defects generally require autologous bone grafts and / or biomaterial implants, to provide mechanical strength and structural support that allows for successful healing. Conventional implants consist of several standard skeletal replacements, of standard size / shape / material, that the surgeon selects, and during surgery adjusts to the size and contour of a given defect. While this approach has been very successful, conventional implants have their drawbacks, such as plate fractures, screw loosening, suboptimal union of bone fragments, and in some cases the size and contour of the given defects are such that standard implants cannot be made to fit.  Patient-Specific Implants (PSI) have been developed to address these difficult cases. Using the latest advances in magnetic resonance (MRI) or computed tomography (CT) imaging, computer aided design (CAD), Finite Element Analysis (FEA) and 3D additive manufacturing (CAM), PSI make it possible to plan, design and manufacture implants, based on 3D virtual planning (VSP), that fit the exact size and contour of skeletal deformities in individual patients (N Borode, et al. 2014). Innovations and rapid expansion in CAD, FEA, and 3D additive manufacturing technologies, combined with a growing awareness of the importance of individualized treatments is enabling the use of PSI in a growing number of reconstructive treatments in the fields of Maxillofacial-, Neuro-, Orthopedic-, and Trauma Surgery (JM Haglin, et al. 2016; Available at: https://www.ricoh- europe.com/news-events/news/7-in-10-healthcare-professionals…; and http://www.personalizedmedicinecoalition.org).

Examples of PSI implants in Neurosurgery, CMF and Orthopedics

Problem:

Despite the seemingly obvious benefits of PSI implants, relatively few cases have been performed compared to treatments using standard over-the-counter implants, so it has been difficult to develop best practice guidelines and compare safety, results, and the economic benefits of PSIs over conventional treatments.  This was highlighted in a recent (April 2019) EUnetHTA Joint Action “meta-analysis” study conducted by the health care regulatory bodies of European Union governments, academia and industry, to determine whether 3D-printed PSI implants and cutting guides improved clinical outcomes in patients undergoing knee, maxillofacial, and cranial surgery. One of the main conclusions of the study was that “… no firm conclusions could be drawn due to“very low or low quality evidence and a lack of clinically or statistically significant results in favor of either technology ”. On this basis, it was concluded that “further research is needed to evaluate patient-related outcomes from the use of 3D printing technology before making a final decision on the continued use of the technology.” (Available in:https://www.defactum.dk ).

Solution:

Based on this conclusion, one of the study collaborators and industry participant, Raomed SA ( https://www.raomed.com.ar ), approached Prof. John H. Barker, Director of Experimental Orthopedics and Surgery of Trauma, at JW Goethe University in Frankfurt, Germany, ( http://firm.uni-frankfurt.de/john-barker ) and together they developed a strategy to address this deficiency. They initiated an effort to develop a comprehensive International PSI Registry, with the following objectives:

  • Collect a sufficient number of quality and standardized PSI results (placement accuracy, range of motion, implant alignment, recovery time, quality of life, pain, aesthetics, preservation of natural bone, etc.), safety (rates complications, infection, resorption, blood loss, tourniquet time, etc.), manufacturing (design characteristics, material and technology used, reticular structures, heat treatment, post-processing; sterilization methods, etc…) and costs (time of operation, re-operation, length of hospitalization, implant lifespan, etc…) data in order to develop best practice guidelines and compare PSIs with conventional treatments.
  • Promote a proactive approach to implement the newly established European Medical Device Regulations (MDR)
  • Provide an easy-to-use roadmap for PSI stakeholders to comply with and enforce the recently established EU MDR Regulation, which mandates that by 2020 “medical device manufacturers should have systematic methods to examine their devices a once they are available in the market, through the systematic collection, recording and analysis of data on safety and performance ”(T Melvin & M Torre, 2019).
  • Help incorporate new MDR requirements as part of the routine protocol for PSI treatments and in doing so come to appreciate its benefits for patients.
  • Assist stakeholders in ISPs involved in planning, manufacturing, use, regulation, and financing, to accurately assess benefits to patients’ health and healthcare compared to other treatments.
  • Publish the PSI Registry data in specialized clinical, scientific and industrial journals, to inform stakeholders about indications for use, design / fabrication optimization, surgical workflows, and costs.
  • Provide PSI users access to real-time clinical results to help healthcare providers make clinical decisions based on a body of scientific knowledge that goes beyond the training, experience or memory of a single professional.
  • Develop a training program for medical students and / or residents to teach them the value of collecting, using, and sharing real-world clinical data to guide healthcare decisions toward the most effective treatments, thereby improving the quality of care , while reducing the need for additional surgeries and the associated high costs.
  • Facilitate knowledge sharing among ISP stakeholders – clinicians, industry, researchers, medical education experts, government regulators, and funders.
  • Use accurate data from PSI clinical, safety, manufacturing, and cost outcomes to support a rational basis for health insurance coverage.
  • Contribute to the development of the “total product life cycle assessment” for ISPs (P McCulloch, et al. 2009).

Finally, this international PSI Registry would serve as a model for developing and implementing other high-risk medical device databases that by facilitating the sharing of real-world data among all stakeholders will help accelerate the development of newer and safer technologies with maximum therapeutic potential to benefit patients.

Partners: This International PIS Registry will be planned, developed and implemented by a multidisciplinary, and multinational team of PSI stakeholders, that include clinical, academic, industry, regulatory and healthcare insurer partners with a broad spectrum of knowledge and experience in all aspects of PSI treatments and industry.

Next steps:

Recruit multinational and multidisciplinary working focus groups of PSI experts, (surgeons, manufactures, researchers, regulators, and insurers) to assist in compiling relevant clinical, manufacturing, scientific, educational, and regulatory parameters to be included in the International PSI Registry. Assign roles of participating entities in planning, developing and implementing the PSI Registry.

  • Develop and submit grant applications to EU-based funding sources and industry partners to cover the expenses associated with establishing, implementing, and maintaining the international PSI Registry.