Back to Press Releases
InSpired Health Outcomes Ltd·Press Release
New Patient-Centred Questionnaire for the Assessment of Dissatisfaction Following Total Knee Replacement
Monday, September 14, 2026
The Leeds Knee Replacement Questionnaire (LKRQ) is a new Patient Reported Outcome (PRO) Measure (or PROM) designed to address long standing gaps in understanding patient satisfaction following Total Knee Replacement (TKR) surgery.
Despite the success of TKR as a procedure, research continues to show that 10-20% of patients remain dissatisfied with their outcomes (Bourne et al., 2010). The current 'gold-standard' PROMs primarily focus on domains such as knee function, ability to return to daily activities and pain reduction. While these domains are essential for evaluating outcomes, they may not fully explain why up to 20% of patients report dissatisfaction following TKR. This limitation becomes particularly evident when patients report ongoing problems or dissatisfaction despite achieving good scores on these measures.
Developed in accordance with FDA guidance on patient-centred methodologies, the LKRQ offers an innovative step forward. Unlike conventional knee PROMs, the LKRQ captures a comprehensive range of patient experiences, including emotional, sensory and perceptions that have until now remained under reported. Examples include sensations of implant heaviness, the impact of temperature, clicking or popping, and perceptions of the knee feeling unnatural.
A Rigorous, Multi Phase Development and Validation Journey
The LKRQ was created through an extensive, multi stage process conducted in accordance with ethical research principles and Good Clinical Practice (GCP), involving:
• Healthcare professional interviews to identify core themes and concepts of interest
• Patient interviews to identify concepts of interest to generate questionnaire item content
• Patient questionnaire completion and cognitive de-briefing in a small cohort and translatability assessment
• Iterative questionnaire testing with patients in a larger cohort across a single UK hospital
• A multi-centre validation study across seven UK hospitals
In the final (to date) validation phase, 166 patients were enrolled, with 160 completing follow up assessments at six months post surgery.
The study demonstrated that using the LKRQ as the primary outcome measure:
• 26.9% of patients remained dissatisfied at six months post TKR
• 74% of these dissatisfied patients reported issues not captured by existing PROMs including the knee feeling unnatural or heavy and sensitivity to heat or cold
• The LKRQ showed the highest sensitivity of all questionnaires assessed compared to EQ-5D-5L and the Oxford Knee Score
Commonly reported issues included difficulty walking uphill (43.8%), sensations of clicking (41.3%), the knee feeling unnatural (40.0%), heaviness (35.6%) and sensitivity to cold (34.5%) or heat (24.4%).
Five final domains were established: activity/daily living, pain/discomfort, locomotion, sensations and temperature. The LKRQ is now considered validated and is suitable for use by surgeons, arthroplasty specialists, orthopaedic registries, healthcare providers, health outcomes researchers, device manufactures and patients worldwide.
A New Global Standard for Post TKR Assessment
With its ability to uncover previously unreported contributors to dissatisfaction, the LKRQ offers clinicians, researchers and medical device developers a richer, more nuanced understanding of patient experiences. Complementary to the Oxford Knee Score, the LKRQ captures previously uncaptured information including patient sensations, temperature sensitivity and perceptions of the knee feeling unnatural. This positions the questionnaire as a vital tool for improving patient care, supporting device innovation and enhancing TKR outcome measurement worldwide.
A New Chapter with InSpired Health Outcomes
As the proud new licensing authority for the LKRQ, InSpired Health Outcomes will:
• Oversee global access and granting permissions (licences) to use;
• Support implementation across clinical and research settings;
• Drive awareness and adoption of this next generation PROM;
• Help facilitate collaborations with surgeons, hospitals, academic groups and industry partners.
Support and Collaboration
This work was kindly supported by Innovate UK [Knowledge Transfer Partnership Grant No: 10004265]. The development of the LKRQ was also supported by KTP Associate Samantha Birts, Professor Hemant Pandit (University of Leeds), Professor Crispin Jenkinson (Harris Manchester College, University of Oxford), Dr Louise Strickland (Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, NDORMS, University of Oxford) and Dr Anthony Moody whose expertise and collaboration were instrumental throughout the project.
For further information, interviews or permission requests, please contact:
Dr. David Churchman
InSpired Health Outcomes Limited
Email: David. Churchman@Inspiredoutcomes.co.uk
Tel +44 (0)7376 920341
Web:- InSpired Health Outcomes | PRO-found®
Despite the success of TKR as a procedure, research continues to show that 10-20% of patients remain dissatisfied with their outcomes (Bourne et al., 2010). The current 'gold-standard' PROMs primarily focus on domains such as knee function, ability to return to daily activities and pain reduction. While these domains are essential for evaluating outcomes, they may not fully explain why up to 20% of patients report dissatisfaction following TKR. This limitation becomes particularly evident when patients report ongoing problems or dissatisfaction despite achieving good scores on these measures.
Developed in accordance with FDA guidance on patient-centred methodologies, the LKRQ offers an innovative step forward. Unlike conventional knee PROMs, the LKRQ captures a comprehensive range of patient experiences, including emotional, sensory and perceptions that have until now remained under reported. Examples include sensations of implant heaviness, the impact of temperature, clicking or popping, and perceptions of the knee feeling unnatural.
A Rigorous, Multi Phase Development and Validation Journey
The LKRQ was created through an extensive, multi stage process conducted in accordance with ethical research principles and Good Clinical Practice (GCP), involving:
• Healthcare professional interviews to identify core themes and concepts of interest
• Patient interviews to identify concepts of interest to generate questionnaire item content
• Patient questionnaire completion and cognitive de-briefing in a small cohort and translatability assessment
• Iterative questionnaire testing with patients in a larger cohort across a single UK hospital
• A multi-centre validation study across seven UK hospitals
In the final (to date) validation phase, 166 patients were enrolled, with 160 completing follow up assessments at six months post surgery.
The study demonstrated that using the LKRQ as the primary outcome measure:
• 26.9% of patients remained dissatisfied at six months post TKR
• 74% of these dissatisfied patients reported issues not captured by existing PROMs including the knee feeling unnatural or heavy and sensitivity to heat or cold
• The LKRQ showed the highest sensitivity of all questionnaires assessed compared to EQ-5D-5L and the Oxford Knee Score
Commonly reported issues included difficulty walking uphill (43.8%), sensations of clicking (41.3%), the knee feeling unnatural (40.0%), heaviness (35.6%) and sensitivity to cold (34.5%) or heat (24.4%).
Five final domains were established: activity/daily living, pain/discomfort, locomotion, sensations and temperature. The LKRQ is now considered validated and is suitable for use by surgeons, arthroplasty specialists, orthopaedic registries, healthcare providers, health outcomes researchers, device manufactures and patients worldwide.
A New Global Standard for Post TKR Assessment
With its ability to uncover previously unreported contributors to dissatisfaction, the LKRQ offers clinicians, researchers and medical device developers a richer, more nuanced understanding of patient experiences. Complementary to the Oxford Knee Score, the LKRQ captures previously uncaptured information including patient sensations, temperature sensitivity and perceptions of the knee feeling unnatural. This positions the questionnaire as a vital tool for improving patient care, supporting device innovation and enhancing TKR outcome measurement worldwide.
A New Chapter with InSpired Health Outcomes
As the proud new licensing authority for the LKRQ, InSpired Health Outcomes will:
• Oversee global access and granting permissions (licences) to use;
• Support implementation across clinical and research settings;
• Drive awareness and adoption of this next generation PROM;
• Help facilitate collaborations with surgeons, hospitals, academic groups and industry partners.
Support and Collaboration
This work was kindly supported by Innovate UK [Knowledge Transfer Partnership Grant No: 10004265]. The development of the LKRQ was also supported by KTP Associate Samantha Birts, Professor Hemant Pandit (University of Leeds), Professor Crispin Jenkinson (Harris Manchester College, University of Oxford), Dr Louise Strickland (Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, NDORMS, University of Oxford) and Dr Anthony Moody whose expertise and collaboration were instrumental throughout the project.
For further information, interviews or permission requests, please contact:
Dr. David Churchman
InSpired Health Outcomes Limited
Email: David. Churchman@Inspiredoutcomes.co.uk
Tel +44 (0)7376 920341
Web:- InSpired Health Outcomes | PRO-found®