PROM assessing patient's emotional wellbeing, and perceptions of TKR
Research type
Research Study
Full title
Development of a new Patient Reported Outcome Measure (PROM) to assess patient’s emotional wellbeing, and perceptions of Total Knee Replacement Surgery (TKR) for the treatment of knee arthritis.
IRAS ID
314891
Contact name
Hemant Pandit
Contact email
Sponsor organisation
Invibio Ltd
Duration of Study in the UK
1 years, 7 months, 21 days
Research summary
Research suggests that 1 in 5 patients express some dissatisfaction with the outcome of their Total Knee Replacement (TKR) Surgery and it is thought that the current knee questionnaires do not identify the reasons for this. Therefore, we would like to develop a new Patient Reported Outcome Measure (PROM) as an adjunct to the current knee questionnaires to assess patient’s emotional wellbeing, and perceptions of Total Knee Replacement (TKR) Surgery, thereby improving future patient care.
Typically, measures such as knee function and need for revision surgery are used as parameters by surgeons to assess patient outcome. However, to gain some insight into patient’s perspectives, a Patient Public Involvement (PPI) session was conducted prior to the project. TKR patients highlighted recurring issues, such as: the weight of the implant, the impact of environmental temperatures, “creaking” and “popping” sounds the implant can make and metal sensitivity and allergies. It is intended that the new PROM will capture this data.
Ethical approval will be obtained for the Planning Phase, Phase One, Phase Two and Phase Three. Amendments will be submitted throughout the project following completion of the previous phase. The Planning Phase and Phase One involve qualitative interviews with Healthcare Professionals and patients undergoing TKR surgery, respectively. Phases Two and Three focus on the development and refinement of pilot questionnaires.
Invibio Ltd are involved in the project as they have developed a new PEEK-OPTIMA™ femoral component (knee implant) which is currently undergoing clinical trials. The overall objective of this research is to produce a new and validated PROM for the future use in patients undergoing TKR with PEEK-OPTIMA™ implants compared to other implant materials.
This project is being conducted by a Knowledge Transfer Partnership Associate in association with the University of Leeds and Invibio Ltd. The project is being funded by Innovate UK and Invibio Ltd.REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0255
Date of REC Opinion
22 Jul 2022
REC opinion
Favourable Opinion