Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT06585267
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2024-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Invibio Ltd
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 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.
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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: