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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis

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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with knee osteoarthritis with an indication of total arthroplasty

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Correlation coefficients between US-TOF measurements and cartilage thickness measurements corresponding to MRI.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the relationship between the propagation velocity of the ultrasound wave in cartilage tissue and the osteoarthritis degree defined by OARSI scale.	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	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.	Correlation coefficients between thickness measurements estimated from MRI data and those estimated from histological data.	5 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Clinical Investigation Centre for Innovative Technology Network; TIMC-IMAG
• Investigators: Principal Investigator: Alexandre Moreau -Gaudry, MD, PhD, Clinical Investigation Centre for Innovative Technology Network - University Hospital Grenoble

Publications and helpful links

Helpful Links

• Description: Clinical Investigation Centre for Innovative Technology Network website

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): July 27, 2017
• Study Completion (Actual): July 27, 2017

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee; Articular cartilage; Ultrasonography evaluation/ultrasound; UltraSound Speed Of Sound (US-SOS); UltraSound Time of Flight (US-TOF)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 38RC17.074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No