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

Orthopedic Disorder Clinical Trial

— FKprefPat  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06100354
• Other study ID #: 29BRC22.0233 - FKprefPat
• Status: Active, not recruiting
• Start date: December 12, 2022
• Est. completion date: June 12, 2024

Study information

• Verified date: October 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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?

Participants will have to answer to a questionnaire of choice.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 12, 2024
• Est. primary completion date: June 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder
• Prosthesis User

Intervention

Other:
• Answering preference
Patients will answer a questionnaire with two possible choices describing several scenario of used of customized and connected prosthesis

Locations

Country	Name	City	State
France	Centre Hospitalo Universitaire de Brest	Brest	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	6 month