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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05597046
Other study ID # SYNC01-PP-USA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 3, 2022
Est. completion date November 5, 2022

Study information

Verified date November 2022
Source Invibio Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

PLANNING PHASE- Qualitative interviews with Healthcare Professionals to assist in the development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement (TKR) surgery for the treatment of knee arthritis.


Description:

The interviews for the SYNC01-PP-USA project will be conducted in person at the American Association of Hip and Knee Surgeons (AAHKS) annual conference in Dallas, Texas, USA during the 3rd, 4th, and 5th November 2022. The interviews will take approximately 30 minutes.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date November 5, 2022
Est. primary completion date November 5, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Healthcare Professionals who currently care for patients who have undergone Total Knee Replacement surgery. - Healthcare Professionals who, in the opinion of the Investigator, can understand the project, co-operate with the interview process and are willing to be interviewed in person. - Healthcare Professionals who are able to give voluntary, written informed consent to participate in this project and from whom consent has been obtained.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interview
Interviews

Locations

Country Name City State
United States AAKHS conference, Dallas Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Invibio Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Interview The interview carried out with the HCPs will ascertain their opinions of the issues that patients report after undergoing TKR. The replies (data) collected could be different for each HCP so there is no outcome measure as such for this data. This information collected will be structured around a set number of questions asked in the interview and will be used to form the potential structure and layout of a Patient Reported Outcome Measure (PROM) and to provide background information for the subsequent Phase One of the project which will take place in the UK. 30 minutes
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