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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06585267

Acronym

SYNC01- P4

Enrollment

167

Registered

2024-09-05

Start date

2024-10-07

Completion date

2027-12-01

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete Questionnaires Following TKR Surgery

Keywords

TKR, Questionnaire

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Validate final questionnaire	From first post-op visit to 36month follow-up	Validation of final questionnaire

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORProfessor Hemant Pandit

Leeds Teaching Hospitals NHS Trust

Outcome results