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

Invibio Ltd1 site in 1 country167 target enrollmentOctober 7, 2024

ConditionsComplete Questionnaires Following TKR Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Complete Questionnaires Following TKR Surgery
Sponsor: Invibio Ltd
Enrollment: 167
Locations: 1
Primary Endpoint: Validate final questionnaire
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 7, 2024

End Date

April 1, 2026

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Invibio Ltd

Responsible Party

Sponsor

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.