ORTHOWATCH

"Integrating outcome registers, retrieval analysis programs and preclinical validation methods into a synergistic post-marketing surveillance program for orthopedic devices"

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 Obiettivo del progetto (Objective)

'There is increasing demand for technology to maintain the mobility of an aging worldwide population. Joint replacement is widely recognized as a successful orthopaedic surgical procedure for treating degenerative musculoskeletal conditions. However, joint replacement prostheses have limited longevity, especially in younger and more active people. Efforts to improve prosthesis longevity and performance continue to drive changes in surgical techniques, prosthesis materials and designs. The broad objective of this proposal is to improve the longevity of joint replacements by expanding our understanding of the biomechanical environment in which prostheses function and wear. The approach is to assess the performance of explanted prostheses after they have endured a finite duration of function in a human physiological environment. Such assessments provide essential inputs for prosthesis development and for validating preclinical methodologies for predicting joint prosthesis performance. However, access to explanted prostheses is limited and few European research groups are participating in such assessments. This proposal (ORTHOWATCH) aims to strengthen the procedures and outcomes of a recently established Register of Orthopaedic Prosthetic Explants (REPO) at the Istituti Ortopedici Rizzoli, a leading European institute for orthopaedics and traumatology. ORTHOWATCH will integrate outcome registers, retrieval analysis programs and preclinical validation methods into a synergistic post-marketing surveillance program for orthopedic devices. The objectives of ORTHOWATCH are: 1) to implement a standardized screening protocol for categorizing explanted prostheses; 2) to apply existing measurement technologies for quantitative assessment of explanted prostheses; and 3) to provide quantitative endpoints from the explanted prostheses that are complementary to the research objectives of a multidisciplinary team of researchers within the host organization.'

Introduzione (Teaser)

Joint replacement can improve quality of life for patients suffering from degenerative musculoskeletal conditions. Increasing the durability of these prosthetics can also help the younger, more active population.

Descrizione progetto (Article)

Ongoing efforts to improve the performance and longevity of joint replacements are important for improved patient mobility. They are also driving innovation in prosthetics design, materials used and the surgical procedures implanting them. This field of biomechatronics is also helping to ease the social and economic burden of joint replacement.

The Orthowatch project's overall aim was to improve the longevity of joint replacements by increasing knowledge of the biomechanical environment in which prostheses function and start to falter. The approach included a systematic assessment of the in vivo performance of prostheses removed (explanted) after a period of use in patients.

Researchers focused on establishing a standardised screening protocol for categorising the numerous explanted joint prostheses provided by the 'Register of orthopaedic prosthetic explants' (REPO). They also set the stage for quantitative assessments of these devices according to how their materials and structure performed in patients. Based on these assessments, the resulting metrics were used to verify that pre-clinical assessments do in fact represent the conditions and clinical performance they were intended for.

Knowledge transfer was enabled by the participation of a PhD post-doc, a PhD engineer, two engineering students, and three biomechanical simulations engineers, and international collaboration with six surgeons and three engineers doing research in England, Germany and the US.

The Orthowatch project is a structured, post-marketing surveillance model that integrates the clinical outcomes from the 'Register of orthopaedic prosthetic implants' (RIPO) with the REPO explant retrieval programme. This lent a positive note to the study with different methodologies being brought together to achieve a holistic level of understanding of joint replacement performance. Advances in this work have provided a standardised framework for conducting pre-clinical assessments to better predict where and how joint replacements will function.