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Active, Not Recruiting

NCT Number: NCT06585267

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chapel Allerton Hospital

Leeds, LS7 4SA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Validate final questionnaire

    Time frame: From first post-op visit to 36month follow-up

    Validation of final questionnaire

Sponsors and collaborators

Lead sponsor

Invibio Ltd

Industry

Collaborators

  • Oxford University Innovation

Registry information

Official study title

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

Acronym: SYNC01- P4

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.