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Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System

Amputation Clinical Trial

Official title:
Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System : a Randomized, Multicenter, Double-blind N-of-1 Trial

Clinical Trial Summary

The aim of this study is to evaluate the contribution of the vacuum suspension system in an ecological environment on the fitting's comfort compared to the vacuum suspension system inactive system in a multicenter prospective, randomized, double-blind, multiple N-of-1 trial. In order to assess the therapeutic effect of the vacuum suspension system, given the heterogeneity of the population and the small number of patients eligible for the study, the multiple N-of-1 trial seems to us to be the methodology. The principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04804150
Study type Interventional
Source Össur Ehf
Contact RENAUD URBINELLI
Phone +33658687286
Email contact@clin-experts.fr
Status Recruiting
Phase N/A
Start date September 11, 2020
Completion date March 2022
View Details
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