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

Recruiting

• Conditions: Complete Questionnaires Following TKR Surgery

• Registration Number: NCT06585267
• Lead Sponsor: Invibio Ltd

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-04
• Study First Posted: 2024-09-05
• Study Start: 2024-10-07
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validate final questionnaire	From first post-op visit to 12month follow-up	Validation of final questionnaire

Trial Locations

Locations (1)

Chapel Allerton Hospital; 🇬🇧 Leeds, United Kingdom