NCT04804150

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Össur Iceland ehf · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	Vacuum suspension system active or inactive	The device will be plugged in, or won't be plugged in, depending of the randomization. The patient and the investigator will not know whether the device is plugged in or not, and if the medical device is active or not

Timeline

• Start date: 2020-09-11
• Primary completion: 2023-05-26
• Completion: 2023-07-10
• First posted: 2021-03-18
• Last updated: 2025-08-11

Locations

3 sites across 1 country: France