Clinical trial NCT03184051: Diagnostic Performance of Ultrasound Imaging Technique for Femoral Condyle Cartilage Evaluation and Osteoarthritis
Official title: Qualification of Ultrasound Imaging Technique in the Quantitative Evaluation of Cartilaginous Tissue of Femoral Condyle Articulation and Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: Knee
Osteoarthritis
Ultrasonography evaluation/ultrasound
Articular cartilage
UltraSound Speed Of Sound (US-SOS)
UltraSound Time of Flight (US-TOF)
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2017-06-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with knee osteoarthritis with an indication of total arthroplasty

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 5 months
Secondary outcomes:
measure: Evaluation of the relationship between the propagation velocity of the ultrasound wave in cartilage tissue and the osteoarthritis degree defined by OARSI scale.
timeFrame: 5 months
measure: Evaluation of the relationship between 3D surface reconstruction and defects of cartilage samples from localized ultrasound data and those derived from MRI data
timeFrame: 5 months
measure: Evaluation of correlation between thickness measured by MRI and this measured by histological analysis.
timeFrame: 5 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Orthopedic Surgery Department, University Hospital, Grenoble
Study officials:
affiliation: Clinical Investigation Centre for Innovative Technology Network - University Hospital Grenoble
name: Alexandre Moreau -Gaudry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: