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

NCT06100354 | Unknown

• 1 other identifier: 29BRC22.0233 - FKprefPat
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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? Participants will have to answer to a questionnaire of choice.

Conditions

Prosthesis User; Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  6 month

Secondary Outcomes (1)

• Measuring the ease of use of new technologies through ATI (Affinity for Technology Interaction) scale

  6 month

Study Arms (1)

Preference study

Patients answering the questionnaire with choice sets

Other: Answering preference

Interventions

Answering preference OTHER

Patients will answer a questionnaire with two possible choices describing several scenario of used of customized and connected prosthesis

Preference study

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Centre Hospitalo Universitaire de Brest

Brest, Brittany Region, 29200, France

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Eric Stindel, PhD

  Centre Hospitalo Universitaire de Brest

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: October 25, 2023
• Study Start: December 12, 2022
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2025
• Last Updated: August 9, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• 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.

Locations

FR (1)