Clinical trial NCT04804150: Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System
Official title: Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System : a Randomized, Multicenter, Double-blind N-of-1 Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amputation
Keywords: Amputation
Elevated vacuum
Prosthetic suspension system
Vacuum-assisted suspension
N-of-1 Trial
Lead sponsor: Össur Iceland ehf
Sponsor class: INDUSTRY
Collaborators: name: Clin-Experts
First posted: 2021-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multiple N-of-1 trial. : the principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Confort change assessment
timeFrame: 50 days
Secondary outcomes:
measure: Change in daily wearing time of the prosthesis
timeFrame: Every day during 50 days
measure: Change in the daily number of steps
timeFrame: Every day during 50 days
measure: Assessment of the stump volume variation
timeFrame: Every day during 50 days
measure: Assessment of limb-prosthesis coaptation
timeFrame: Every day during 50 days
measure: Change L-Test of Functional Mobility
timeFrame: Up to 50 days
measure: Change in 6 Minute Walk Test (6MWT)
timeFrame: Up to 50 days
measure: Change in patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
timeFrame: Up to 50 days
measure: Change in confidence in maintaining balance while doing daily activities
timeFrame: Up to 50 days
Other outcomes:
Locations:
city: Aubagne
country: France
facility: Clinique de Provence-Bourbonne
city: Bruges
country: France
facility: La Tour de Gassie
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: LA TOUR DE GASSIES
name: REMI KLOTZ, MD
role: PRINCIPAL_INVESTIGATOR
References: