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

  • End date
    Mar 25, 2022
  • participants needed
  • sponsor
    Össur Ehf
Updated on 25 March 2021


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.

Condition Amputation, Limb Preservation and Amputation
Treatment Vacuum suspension system active or inactive
Clinical Study IdentifierNCT04804150
SponsorÖssur Ehf
Last Modified on25 March 2021


Yes No Not Sure

Inclusion Criteria

Male or female over 18 years of age
Unilateral transtibial amputation for more than 6 months
Equipped for more than 3 months with a Seal-in liner without the vacuum suspension system
Equipped with an ESAR(Energy Storing and Return) foot with the vacuum suspension system
Patient meeting the criteria of ICF(International Classification of Functioning, Disability and Health) classification d4602 and/or d4608
Presenting some discomfort in the socket evaluated by a SCS 7/10
Absence of severe comorbidity
Patient with a smartphone and a functional 4G connection

Exclusion Criteria

Cognitive impairment that does not allow instructions to be followed
Have already been equipped with the evaluated vacuum suspension system
Pregnant women
Patient subject to a legal protection measure
Patient not affiliated with social security
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