Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585267
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Development of a New Patient Reported Outcome Measure PROM to Assess Patients Emotional Wellbeing and Perceptions of Total Knee Replacement Surgery for the Treatment of Knee Arthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of a New Patient Reported Outcome Measure PROM to Assess Patients 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:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SYNC01- P4
Brief Summary:
Development of a new Patient Reported Outcome Measure PROM to assess patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None