Study of Patient Preferences in Relation to the Fitting of a Personalized and Connected Joint Prosthesis. (FKprefPat)

October 19, 2023 updated by: University Hospital, Brest

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bretagne
      • Brest, Bretagne, France, 29200
        • Centre Hospitalo Universitaire de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The target population is the population that comes for consultation and needs a hip, knee or shoulder replacement.

Description

Inclusion Criteria:

  • More than 18
  • Non opposition expressed
  • Should have a hip, knee or shoulder joint replacement

Exclusion Criteria:

  • Opposition expressed
  • Having already a hip, knee or shoulder joint prosthesis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preference study
Patients answering the questionnaire with choice sets
Other: Answering preference
Patients will answer a questionnaire with two possible choices describing several scenario of used of customized and connected prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring the ease of use of new technologies through ATI (Affinity for Technology Interaction) scale
Time Frame: 6 month

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).
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Study Director: Eric Stindel, PhD, Centre Hospitalo Universitaire de Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Estimated)

June 12, 2024

Study Completion (Estimated)

June 12, 2024

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC22.0233 - FKprefPat

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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