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NCT06585267 | RECRUITING | Complete Questionnaires Following TKR Surgery

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
Sponsor:

Invibio Ltd

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.

Condition or disease

Complete Questionnaires Following TKR Surgery

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 150 participants
Official 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
Actual Study Start Date : 2024-10-07
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
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

Location Details

NCT06585267

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United Kingdom,

Chapel Allerton Hospital

Leeds, United Kingdom, LS7 4SA