Phase Four - Validation of Final Questionnaire V2.0
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 for the treatment of knee arthritis.
IRAS ID
342818
Contact name
Hemant Pandit
Contact email
Sponsor organisation
Invibio Ltd
Clinicaltrials.gov Identifier
TBC, Clinical Trials website
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
Research suggests that some 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. Invibio Ltd were interested to understand the reasons for this and were awarded a two year government grant to work with Professor Hemant Pandit at Chapel Allerton Hospital in Leeds. This project is now completed (IRAS Ref No 314891) and the team have developed a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement surgery for the treatment of knee arthritis. This final questionnaire is call the Leeds Knee Replacement Questionnaire (LKRQ).
This study is the validation of the LKRQ (PROM) in Phase Four. Patients will complete the LKRQ for quantitative analysis only (involves no administration of any medicinal products or medical devices) and is considered a low-risk research project.
Along with the LKRQ there will be five supplementary questions provided to the patients (called the Leeds Knee Replacement Questionnaire-Supplementary Questions). These supplementary questions are stand-alone and will be completed at the same time as the LKRQ, but will not form part of the validation process. Patients will also be asked to complete the already validated EQ-5D-5L and Oxford Knee Score questionnaires.Patients will complete the three questionnaires including the LKRQ-Supplementary Questions at their first visit post-surgery (anywhere between 6 to 12 weeks, designated Visit 1), and then 6 months (designated Visit 2) and 12 months (completed via post) following standard Total Knee Replacement surgery. The questionnaires completed at Visit 1 and Visit 2 will be used to validate the LKRQ only. The questionnaires completed at 12 months via post will be used to assess longer term responses.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0204
Date of REC Opinion
18 Jun 2024
REC opinion
Further Information Favourable Opinion