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Diagnostic Performance of Ultrasound Imaging Technique for Femoral Condyle Cartilage Evaluation and Osteoarthritis (CARTILAGE)

10. september 2018 opdateret af: University Hospital, Grenoble

Qualification of Ultrasound Imaging Technique in the Quantitative Evaluation of Cartilaginous Tissue of Femoral Condyle Articulation and Osteoarthritis

This study investigates the potential of the ultrasound imaging technique to diagnose the severity of knee osteoarthritis (OA). In parallel, measurements will also be conducted using Magnetic Resonance Imaging (MRI) and histology analysis as reference tools.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Knee osteoarthritis (OA) is a common degenerative disease of synovial joint becoming more frequent with age. Among techniques have been used to diagnose and classify the severity of knee OA, the imaging techniques, such as ultrasonography (US), provide physical quantitative informations for better understanding and assessing of the pathology of the knee joint.

The present study aim to investigate the diagnostic performance of ultrasonography for femoral condyle cartilage evaluation using MRI and histology analysis as reference tools. To validate this approach, evaluations are conducted to determine, whether the UltraSound Speed Of Sound (US-SOS) propagation is associated with the variation of the arthrosis stage, in order to improve the diagnosis of the surgeon. For this purpose, measurements are conducted using selected human cartilage samples with different stage of OA (early stage and advanced stage).

This research is the first "preclinical" study of a new unlabelled medical device developed by Cartimage Medical SAS. Cartilage is a prospective, monocentric, unrandomized and uncontrolled study. This study doesn't modify the medical care of the patient.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

16

Kontakter og lokationer

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

Studiesteder

  • Frankrig
      • Grenoble, Frankrig, 38043
        • Orthopedic Surgery Department, University Hospital, Grenoble

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with knee osteoarthritis with an indication of total arthroplasty

Beskrivelse

Inclusion Criteria:

  • patient over 18 year old
  • knee osteoarthritis which total knee arthroplasty indication
  • who have signed a non-objection form.

Exclusion Criteria:

  • person who refuse to sign a non-objection form
  • person deprived of liberty by judicial or administrative decision
  • person under legal protection or unable to express their consent
  • person hospitalized for psychiatric care

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Ultrasound assessment
All subject of the study have a knee osteoarthritis (OA) and are going to have a total arthroplasty. Diagnostic performance of ultrasonography is evaluated on ex vivo cartilage samples (2 samples per patient are selected with different stage of OA : 1 with early stage and 1 with advanced stage).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of the correlation between the Time of Flight (TOF) of ultrasounds between the two interfaces (bone / cartilage and cartilage / water) and the real thickness of the cartilage measured by Magnetic Resonance Imaging (MRI).
Tidsramme: 5 months
Correlation coefficients between US-TOF measurements and cartilage thickness measurements corresponding to MRI.
5 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of the relationship between the propagation velocity of the ultrasound wave in cartilage tissue and the osteoarthritis degree defined by OARSI scale.
Tidsramme: 5 months

Correlation coefficients between the US propagation velocity measurements and OA progression according to the seven groups of the OARSI scale.

Position indicators of US propagation velocity measurements of the 2 groups "early stage" (0 <= OARSI <= 2) and "advanced stage" (3 <= OARSI <= 6).
5 months
Evaluation of the relationship between 3D surface reconstruction and defects of cartilage samples from localized ultrasound data and those derived from MRI data
Tidsramme: 5 months

Correlation coefficient between surface area of samples and defects estimated from ultrasound data and those derived from MRI data.

Correlation coefficients between surface volumes of samples and defects estimated from ultrasound data and those derived from MRI data.
5 months
Evaluation of correlation between thickness measured by MRI and this measured by histological analysis.
Tidsramme: 5 months
Correlation coefficients between thickness measurements estimated from MRI data and those estimated from histological data.
5 months

Samarbejdspartnere og efterforskere

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

Sponsor

University Hospital, Grenoble

Samarbejdspartnere

Clinical Investigation Centre for Innovative Technology Network
TIMC-IMAG

Efterforskere

  • Ledende efterforsker: Alexandre Moreau -Gaudry, MD, PhD, Clinical Investigation Centre for Innovative Technology Network - University Hospital Grenoble

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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 (Faktiske)

15. juni 2017

Primær færdiggørelse (Faktiske)

27. juli 2017

Studieafslutning (Faktiske)

27. juli 2017

Datoer for studieregistrering

Først indsendt

8. juni 2017

Først indsendt, der opfyldte QC-kriterier

9. juni 2017

Først opslået (Faktiske)

12. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 38RC17.074

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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