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

NCT06585267 | Active Not Recruiting

• 1 other identifier: SYNC01- P4
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Complete Questionnaires Following TKR Surgery

Keywords

TKR; Questionnaire

Outcome Measures

Primary Outcomes (1)

• Validate final questionnaire

  Validation of final questionnaire

  From first post-op visit to 36month follow-up

Study Arms (1)

Main patient Group

Patients who have undergone Total Knee Replacement (TKR) Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are due to undergo TKR surgery or have undergone TKR surgery in the last 3 months.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Invibio Ltd: lead
• Oxford University Innovation: collaborator

Study Sites (1)

Chapel Allerton Hospital

Leeds, LS7 4SA, United Kingdom

Location

Study Officials

• Professor Hemant Pandit

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)