Total Knee ReplacementNCT05597046
Qualitative Interviews With Healthcare Professionals
An observational study of Total Knee Replacement, run by Invibio Ltd at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Interview
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 5 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Healthcare Professionals attending the AAKHS conference, Dallas during Thursday 3rd to Saturday 5th November 2022.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed 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.
- Conditions
- Total Knee Replacement
- Being tested
- Interview
- Keywords
- TKR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Interviews
| Study group | Role | What they receive |
|---|---|---|
| Healthcare Professionals | Planning Phase Interviews Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start3 Nov 2022
- Primary completion5 Nov 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invibio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597046
- Sponsor's protocol ID
- SYNC01-PP-USA
- Status last verified
- Nov 2022
- First submitted
- 25 Oct 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05597046
- Acronym / sponsor ID
- SYNC01-PP-USA
- Conditions
- Total Knee Replacement
- Keywords
- TKR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Invibio LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare Professionals | – | Other: InterviewPlanning Phase Interviews |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthcare Professionals attending the AAKHS conference, Dallas during Thursday 3rd to Saturday 5th November 2022.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewInterviews | Other | Healthcare Professionals |
Primary outcome
Interview
Time frame: 30 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Replacement, run by Invibio Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interview (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.