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Completed

NCT Number: NCT03184051

Diagnostic Performance of Ultrasound Imaging Technique for Femoral Condyle Cartilage Evaluation 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopedic Surgery Department, University Hospital, Grenoble

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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).

    Time frame: 5 months

    Correlation coefficients between US-TOF measurements and cartilage thickness measurements corresponding to MRI.

Secondary outcomes

  1. Evaluation of the relationship between the propagation velocity of the ultrasound wave in cartilage tissue and the osteoarthritis degree defined by OARSI scale.

    Time frame: 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).

  2. Evaluation of the relationship between 3D surface reconstruction and defects of cartilage samples from localized ultrasound data and those derived from MRI data

    Time frame: 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.

  3. Evaluation of correlation between thickness measured by MRI and this measured by histological analysis.

    Time frame: 5 months

    Correlation coefficients between thickness measurements estimated from MRI data and those estimated from histological data.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Clinical Investigation Centre for Innovative Technology Network
  • TIMC-IMAG

Registry information

Official study title

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

Acronym: CARTILAGE

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 12, 2017
Registry last updated
Sep 11, 2018

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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