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Completed

NCT Number: NCT04791163

Above-knee Socket Evaluation : Sub-ischial vs Ischial Containment

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.

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Key information

Conditions

Lower Limb Amputation Above Knee (Injury) Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Les Capucins, Angers, France

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About this study

Subjects wearing ischail containment sockets will be proposed to enter the research. They will be provided and fitted with a sub-ischial socket. Randomly, they will use one or the other socket for four weeks, then be tested : finctional test and questionnaires. After this testing session, they will use the other socket, and be re-tested accordingly.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • can give informed consent
  • aged 18 or more
  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Socket evaluation

Device

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

Primary outcomes

  1. Comfort evaluation

    Time frame: 1 minute

    Socket Comfort Score (SCS)

Secondary outcomes

  1. Comfort evaluation in various situations

    Time frame: 1 minute

    Same question for four detailed situations

  2. Locomotor capability

    Time frame: 5 minutes

    PLUS-M questionnaire and 2-minute walking test

Sponsors and collaborators

Lead sponsor

Proteor Group

Industry

Registry information

Official study title

AK Socket Evaluation : Sub-ischial vs Ischial Containment. Multi-center Randomised Crossover Study

Acronym: P20-EMBSUBI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2021
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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