Clinical trial NCT06585267: 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
Official 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 Phase Four - Validation of Final Questionnaire This Phase is to Validate the Final Questionnaire in Terms of Reliability, Validity and Ability to Detect Change
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complete Questionnaires Following TKR Surgery
Keywords: TKR
Questionnaire
Lead sponsor: Invibio Ltd
Sponsor class: INDUSTRY
Collaborators: name: Oxford University Innovation
First posted: 2024-09-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are due to undergo TKR surgery or have undergone TKR surgery in the last 3 months.

Brief summary: 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.

Detailed description: Patients will complete the final developed questionnaire for quantitative analysis only (involves no administration of any medicinal products or medical devices) and is considered a low-risk project.

Patients will also be asked to complete the already validated EQ-5D-5L and Oxford Knee Score questionnaires at the same time as the final developed questionnaire following their Total Knee Replacement surgery.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years of age or older.
* Patients who have undergone Total Knee Replacement surgery with a metal implant for the treatment of end-stage knee arthritis in the last 3 months.
* Patients who have only undergone one Total Knee Replacement surgery on the index knee.
* Patients who, in the opinion of the Investigator, are able to understand this project and co-operate with the requirements of participation.
* Patients who are able to give voluntary, written informed consent to participate in this project and from whom consent has been obtained.

Exclusion Criteria:

* Patients, who in the opinion of the Investigator, exhibit evidence of any condition or co-morbidity that would compromise their participation in the project.
* Patients who are unable to understand and communicate fluently in English.
* Patients who have experienced a complication following Total Knee Replacement surgery requiring a further hospital admission or revision surgery to the index knee.

Primary outcomes:
measure: Validate final questionnaire
timeFrame: From first post-op visit to 12month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
Study officials:
affiliation: Leeds Teaching Hospitals NHS Trust
name: Professor Hemant Pandit
role: PRINCIPAL_INVESTIGATOR
References: