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

NCT ID: NCT06585267

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-07
• Study Completion Date: 2026-04-30

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.

Conditions

Complete Questionnaires Following TKR Surgery

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Main patient Group

Patients who have undergone Total Knee Replacement (TKR) Surgery

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford University Innovation

UNKNOWN

Sponsor Role: collaborator

Invibio Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor Hemant Pandit

Role: PRINCIPAL_INVESTIGATOR

Leeds Teaching Hospitals NHS Trust

Locations

Chapel Allerton Hospital

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

SYNC01- P4

Identifier Type: -

Identifier Source: org_study_id