NCT04791163

Completed

Above-knee Socket Evaluation : Sub-ischial vs Ischial Contai...

Proteor Group Source

Compare

Other study identifiers

Sponsor study identifier

2020-A03303-36

Study Type

interventional

Actual enrollment (reported)

25

Locations

1 country

Sites

9

Timeline

Study Start

April 15, 2021

Actual (reported)

Primary Completion

July 1, 2022

Actual (reported)

Study Completion

July 1, 2022

Actual (reported)

Brief Summary

Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 25 participants
Study completion date: July 1, 2022
Actual (reported)
Listed locations: 1 countries · 9 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 8, 2021
Actual (reported)
First Posted
March 10, 2021
Actual (reported)
Study Start
April 15, 2021
Actual (reported)
Primary Completion
July 1, 2022
Actual (reported)
Study Completion
July 1, 2022
Actual (reported)

Last Updated: August 9, 2022
Status Verified: August 2022
Last Update Submitted: August 8, 2022

Conditions

Lower Limb Amputation Above Knee (Injury)

Outcome Measures

Primary Outcomes (1)

Comfort evaluation
Socket Comfort Score (SCS)
1 minute

Secondary Outcomes (2)

Comfort evaluation in various situations
1 minute
Locomotor capability
5 minutes

Study Arms (2)

Sub-ischial socket

EXPERIMENTAL

Start using the sub-ischial socket for four weeks and be tested with this socket.

Device: Socket evaluation

Ischial containment socket

ACTIVE COMPARATOR

Start using the ischial containment socket for four weeks and be tested with this socket.

Device: Socket evaluation

Interventions

Socket evaluationDevice

The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test

Ischial containment socketSub-ischial socket

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

can give informed consent
aged 18 or more

Sponsors & Collaborators

Proteor Group
Industrylead

Study Sites (9)

Les Capucins

Angers, 49100, France

UGECAM La Tour de Gassies

Bruges, 33523, France

Clinique du Cabirol

Colomiers, 31771, France

Hôpital Léon Bérard

Hyères, 83418, France

UGECAM - IRR Nancy

Nancy, 54000, France

Institution Nationale des Invalides

Paris, 75007, France

Centre Mutualiste de Kerpape

Ploemeur, 56275, France

MeSH Terms

Conditions

Wounds and Injuries

Enrollment

25 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 10, 2021

Study Start

April 15, 2021

Actual (reported)

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Evaluation of a Motorised Prosthetic Knee

Not ApplicableCompleted

NCT03376919

The CYBERnetic Lower Limb Cocognitive Ortho-prosthesis Plus Plus, 1st Clinical Study (CLs++)

Not ApplicableUnknown

NCT02765035

C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees

Not ApplicableCompleted

NCT02240186

Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees

Not ApplicableCompleted

NCT06635655

Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.

Recruiting

NCT06522646

Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)

Not ApplicableCompleted

above-knee amputee, wearing a definitive ischial containment socket

stump longer than 16cm

wearing a liner, whatever the suspension system

able to walk (d4600, d4601, d4602, d4608 accordinf to IFC)

unilaterla or bilateral amputee

able to done the socket standing

whatever the etiology

You may not qualify if:

protected person
pregnant woman or nursing mother
subject having comorbidities heavily impacting feeling or socket donning
allergic to silicon
suffering from big volume variations in a same day
infecté stump (may lead to lymphatic problems)

Contact the study team to confirm eligibility.

UGECAM La Tourmaline

Saint-Herblain, 44818, France

CHBA Vannes

Vannes, 56000, France

Primary Completion

July 1, 2022

Actual (reported)

Study Completion

July 1, 2022

Actual (reported)

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04791163
Data provider: ClinicalTrials.gov
Source updated: 2022-08-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:41 UTC

Locations

FR(9)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Sub-ischial socket

Ischial containment socket

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations