Bridging the gap between industry, academia, and real-world clinical challenges in total knee replacement

Sheryl O'Farrell
Head of Clinical Development - Invibio

Q+A with Invibio’s Clinical Development Team

Invibio has recently celebrated the completion of 2-year project, as part of a Knowledge Transfer Partnership (KTP) scheme with University of Leeds. Now, as it wraps up, the team at Invibio look ahead to the impact it will have on our mission to advance clinical outcomes in orthopaedic patient care. 

Led by a dedicated team at Invibio and in collaboration with the University of Leeds, the partnership is bridging the gap between patients, surgeons, and industry. We caught up with Invibio’s Head of Clinical Development, Dr Sheryl O’Farrell; and Knowledge Transfer Partnership and Research Associate Samantha Birts to tell us more. 

Sheryl O'Farrell

Dr Sheryl O'Farrell

Samantha Birts

Q: What is a Knowledge Transfer Partnership? 

Sheryl: A Knowledge Transfer Partnership (KTP) is a collaborative initiative facilitated by Innovate UK - the UK’s national innovation agency – it connects industry with academia to undertake innovative projects together. Through the structured partnership, Invibio worked with University of Leeds to apply academic knowledge to the real-world challenges that patients are experiencing after undergoing total knee replacement (TKR) surgery. 

Q: Could you provide an overview of the project? 

Samantha: The project centered around the development of a new Patient Reported Outcome Measure (PROM) aimed at assessing patients' emotional well-being and perceptions of total knee replacement surgery for the treatment of knee arthritis.
Orthopedic physician asking a patient questions about their knee replacement surgery

Over the course of the 2-year project, extensive research was conducted, involving interviews with healthcare professionals and patients undergoing total knee replacement surgery.  This collaborative effort culminated in the creation of a new knee questionnaire designed to capture crucial patient data on various aspects of their experience. 

We have also worked closely with Professor Crispin Jenkinson based at Oxford University, who was involved in the development of the Oxford Knee Score, to ensure the validity of the work conducted. 

This is the first time a commercial organisation has embarked on knowledge transfer from a patient to a surgeon and then to a company directly.

Q: What motivated Invibio to embark on this project?

Sheryl: We know that there is a high dissatisfaction among TKR patients, with many reporting recurring issues, such as: the weight of the implant, the impact of environmental temperatures, “creaking” and “popping” sounds the implant can make, and sensitivities to metal implants. 

Orthopedic physician examining a patient after total knee replacement
It’s estimated that approximately 1 in 5 patients express discontent with surgery outcomes and it is not yet clear exactly why that is
Sheryl O’Farrell 
Head of Clinical Development

Sheryl: Clinicians use patient questionnaires to measure a range of patient factors, however existing knee questionnaires are not designed to identify the root causes of dissatisfaction. So, Invibio aimed to fill this crucial gap by developing a novel questionnaire in accordance with FDA regulations, that allows for a more holistic evaluation of outcomes beyond traditional metrics like knee function, and delves deeper into patients' experiences by addressing concerns ranging from implant weight to environmental impacts and material sensitivities.  

Samantha: The questionnaire has been carefully developed to be impartial, and one important factor in this has been to collaborate with patients to ensure that not only are the questions valid and understood, but that they really focus on the outcomes that are most important to patients.   

Q: What has the partnership meant for you, Sam? 

Samantha: It was a great privilege to represent University of Leeds as the Research Associate for this project. I was able to apply research knowledge and my own practical clinical experience to help deliver something that I believe has the potential to help advance the way in which we understand patient needs. The project also enables professional development for me - coinciding with Invibio opening a new orthopedic medical device product development and manufacturing centre, which allowed me to tap into a broad range of medical device design expertise. 

Q: What’s next for the questionnaire? 

Sheryl: With the successful conclusion of the project, Invibio is gearing up for the next phase of validation and implementation. The newly developed knee questionnaire will undergo validation in a study with hospitals in the UK, under the guidance of Professor Pandit and the clinical team at Invibio. This marks a pivotal moment in the journey towards enhancing patient care and improving surgical outcomes. The future plan is to use this questionnaire in patients undergoing surgery with PEEK-OPTIMA™ implants so we can compare the results to other implant materials.

A PEEK-OPTIMA™ femoral knee component for primary total knee arthroplasty (TKA)
Image: A PEEK-OPTIMA™ femoral knee component for primary total knee arthroplasty (TKA)

Closing statement: The successful collaboration between Invibio and the University of Leeds demonstrates the power of partnerships in driving innovation and addressing real-world challenges in healthcare. Through initiatives like the Knowledge Transfer Partnership, we are not only bridging the gap between industry, academia, and clinical practice but also paving the way for a brighter future in healthcare innovation.
Learn more about Invibio’s device development solutions for knee.

About the authors

  • Dr Sheryl O’Farrell has 30 years' experience in medical device development, encompassing all aspects from Quality to Clinical Operations. She now leads the Clinical team at Invibio, collaborating with academic institutions

  • Samantha Birts holds a degree in Biomedical Science with Physiology and Pharmacology from Leeds Beckett University and has clinical experience as a Registered Midwife in the NHS and is an alumnus of University of Leeds. Since 2022, she has been the driving force of the KTP partnership between University of Leeds and Invibio. 

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