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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-15

Study Completion Date

2017-07-27

Brief Summary

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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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Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No