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

Össur Iceland ehf

Status: Completed

Conditions: Amputation

Treatments: Device: Vacuum suspension system active or inactive

Study type: Interventional

Funder types: Industry

Identifiers

NCT04804150

2020-A01309-30

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Medical Device active or inactive

Experimental group

Description:

The medical device will be active, or inactive. Randomization will define when and how long time the medical device will plugged and active, and when and how long time the medical device will be unplugged and inactive. The patient won't know if the medical device is active or not

Treatment:

Device: Vacuum suspension system active or inactive