Prosthesis UserFKprefPatNCT06100354
Study of Patient Preferences in Relation to the Fitting of a Personalized and Connected Joint Prosthesis.
An observational study of Prosthesis User and Orthopedic Disorder, run by University Hospital, Brest at 1 site in France.
Trial summary
The goal of this observational study is to learn about patients' preference toward the use of customized and connected prosthesis. The main questions it aims to answer are: What is the acceptability of new customization and connectivity technologies by patients? Are they all at the same level of acceptability?… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis User, Orthopedic Disorder
- What is being tested?
- Answering preference
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2022to 12 Jun 2025
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population is the population that comes for consultation and needs a hip, knee or shoulder replacement.
Who may be able to join
- More than 18
- Non opposition expressed
- Should have a hip, knee or shoulder joint replacement
Who cannot join
- Opposition expressed
- Having already a hip, knee or shoulder joint prosthesis
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalo Universitaire de Brest
Brest, Brittany Region, 29200
About this study
The goal of this observational study is to learn about patients' preference toward the use of customized and connected prosthesis. The main questions it aims to answer are:
- What is the acceptability of new customization and connectivity technologies by patients?
- Are they all at the same level of acceptability?
Participants will have to answer to a questionnaire of choice.
- Conditions
- Prosthesis User, Orthopedic Disorder
- Being tested
- Answering preference
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Answering preferenceOther
Patients will answer a questionnaire with two possible choices describing several scenario of used of customized and connected prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Preference study | Patients answering the questionnaire with choice sets Receives: Other: Answering preference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gathering preferences for a customized and connected prosthesis by Discrete choice analysis, and with a questionnaire called "Discrete Choice Experiment", based on RUT (Random Utility Theory).
Patient will choose one scenario between the two proposed in the eight choice sets. Then, based on RUT (Random Utility Theory), a conditionnal logit and Mixed logit will be used to calculate the beta coefficiants of the attributes that allow to measure the prefered choice relating to the technology tested
Measured: 6 month
Secondary outcomes (1)
Measuring the ease of use of new technologies through ATI (Affinity for Technology Interaction) scale
Several question about the use of technologies by patients in their daily life are asked.
Scale ranges from 1-2 (very low affinity) to 5-6 (very high affinity).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start12 Dec 2022
- Primary completion12 Jun 2024
- Study completion12 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis UserStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Stindel, PhD, Study director, Centre Hospitalo Universitaire de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100354
- Sponsor's protocol ID
- 29BRC22.0233 - FKprefPat
- Acronym
- FKprefPat
- Status last verified
- Oct 2023
- First submitted
- 19 Jan 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Patient Preferences in Relation to the Fitting of a Personalized and Connected Joint Prosthesis.
- ClinicalTrials.gov ID
- NCT06100354
- Acronym / sponsor ID
- FKprefPat / 29BRC22.0233 - FKprefPat
- Conditions
- Prosthesis User, Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2025 (estimated)
- First posted
- 25 Oct 2023 (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.
The goal of this observational study is to learn about patients' preference toward the use of customized and connected prosthesis. The main questions it aims to answer are:
- What is the acceptability of new customization and connectivity technologies by patients?
- Are they all at the same level of acceptability?
Participants will have to answer to a questionnaire of choice.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preference study | – | Other: Answering preferencePatients answering the questionnaire with choice sets |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is the population that comes for consultation and needs a hip, knee or shoulder replacement.
Key inclusion criteria (3 listed)
- More than 18
- Non opposition expressed
- Should have a hip, knee or shoulder joint replacement
Key exclusion criteria (2 listed)
- Opposition expressed
- Having already a hip, knee or shoulder joint prosthesis
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 |
|---|---|---|
| Answering preferencePatients will answer a questionnaire with two possible choices describing several scenario of used of customized and connected prosthesis | Other | Preference study |
Primary outcome
Gathering preferences for a customized and connected prosthesis by Discrete choice analysis, and with a questionnaire called "Discrete Choice Experiment", based on RUT (Random Utility Theory).
Time frame: 6 month
Patient will choose one scenario between the two proposed in the eight choice sets. Then, based on RUT (Random Utility Theory), a conditionnal logit and Mixed logit will be used to calculate the beta coefficiants of the attributes that allow to measure the prefered choice relating to the technology tested
1 secondary outcome
Measuring the ease of use of new technologies through ATI (Affinity for Technology Interaction) scale
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Prosthesis User
Active, not recruiting
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
Lower Extremity Amputee, Diabetic Peripheral Neuropathy
Recruiting
Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
Not yet recruiting
Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
Unilateral Transfemoral Amputation in Prosthetic Users
Recruiting
Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis
Prosthesis User, Prosthesis
Active, not recruiting
Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration
Amputation, Prosthesis User
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.
Eric Stindel, PhD study director
Centre Hospitalo Universitaire de Brest
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 Prosthesis User and Orthopedic Disorder, run by University Hospital, Brest at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. 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 France. 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?
Results are not available in the source record.
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?
Gathering preferences for a customized and connected prosthesis by Discrete choice analysis, and with a questionnaire called "Discrete Choice Experiment", based on RUT (Random Utility Theory). (time frame: 6 month). 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 Aug 2024.