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Thigh Reduction Surgery of Above Knee Amputee Residual Limbs to Improve Prosthesis Fit and Patient Outcomes

19. marts 2020 opdateret af: Todd Kuiken, Shirley Ryan AbilityLab

Thighplasty of Transfemoral Amputee Residual Limbs to Improve Prosthesis Fit and Patient Functional Outcomes

The purpose of our study is to improve the fit and function of prosthetic sockets for above the knee amputees through the use of an outpatient thigh reduction surgical procedure.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

We will quantify the anatomical distribution of subcutaneous fat, muscle and bone in the residual limb of the transfemoral amputees with an MRI. We will measure the displacement of the socket wall relative to the femur under mechanical loading with x-ray. The functional mobility level of the subject with be quantified via standard clinical and bio mechanical tests. Perform a standard medial thighplasty with our without thigh liposuction. Characterize the post-surgical anatomy, compliance of the residual limb and function of the amputee subjects. After six months, repeat the MRI and xray and compare results. Subject will also complete a questionnaire regarding their views on the outcome of the surgery.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Rehabilitation Institute of Chicago

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Obese transfemoral amputees with a BMI of at least 30.
  • Mid to long residual limb, excessive adipose tissue in their residual limb
  • Community ambulators
  • Adults over the age of 18

Exclusion Criteria:

  • Amputation due to vascular disease or diabetes
  • Cognitive impairments that would interfere with the protocol or patient safety
  • Systemic disease that is not stable or would significantly increase the risk of complications with surgery
  • Chronic wounds
  • People who do not ambulate on a daily basis
  • Children under the age of 18.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Surgical: Medial thighplasty
Perform a standard medial thighplasty with our without additional thigh liposuction on up to three obese transfemoral amputee subjects. The surgery will consist of medial excision of excess adipose and cutaneous tissue with circumferential liposuction.
Procedure: Medial thighplasty with or without thigh liposuction
Perform a standard medial thighplasty with or without additional thigh liposuction on up to three obese transfemoral amputee subjects. The subjects will be transfemoral amputees who are successful ambulators and have a body mass index (BMI) of 30 or greater with excessive adipose tissue in their residual limb. The surgery will consist of medial excision of excess adipose and cutaneous tissue with circumferential liposuction.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assess compliance of residual limb in the socket, which will improve the fit and comfort of the prosthesis.
Tidsramme: Pre surgery and 6 months post surgery
We will measure the compliance of their residual limb by the displacement of the socket wall relative to the femur under mechanical loading with X-ray. The subjects will adjust their foot placement, limb loading and muscle contractions to achieve up to 8 specified force/torque levels (as measured by a 6 degree-of-freedom load cell located in series with their pylon and socket), which correspond to forces and torques that are typical of over ground walking and standing postures and are scaled for their body weight. For each force/torque level, static X-ray scans of locations of the prosthetic socket wall and residual limb femur will be acquired.
Pre surgery and 6 months post surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assess walking endurance
Tidsramme: Pre surgery and 6 months post surgery
Complete 6 minute walk test over level ground as metabolic energy consumption and heart rate our monitored. Subjects may wear a portable, commercially available metabolic measurement system so that their metabolic energy expenditure may be calculated after the experiment.
Pre surgery and 6 months post surgery
Assess balance stability
Tidsramme: Pre surgery and 6 months post surgery
Complete the 4 square step test as a clinical test of the ability to change directions while stepping.
Pre surgery and 6 months post surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shirley Ryan AbilityLab

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2014

Primær færdiggørelse (Faktiske)

1. august 2019

Studieafslutning (Faktiske)

1. marts 2020

Datoer for studieregistrering

Først indsendt

9. januar 2015

Først indsendt, der opfyldte QC-kriterier

19. januar 2015

Først opslået (Skøn)

26. januar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • STU00090292

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Transfemorale amputerede

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner