Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Invibio Ltd
Collaborating Sponsors:
Oxford University Innovation
Conditions:
Complete Questionnaires Following TKR Surgery
Eligibility:
All Genders
18+ years
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT06585267
Start Date
October 7 2024
End Date
April 1 2026
Last Update
November 19 2025
Active Locations (1)
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1
Chapel Allerton Hospital
Leeds, United Kingdom, LS7 4SA