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

Knee Osteoarthritis Clinical Trial

— CARTILAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184051
• Other study ID #: 38RC17.074
• Status: Completed
• Start date: June 15, 2017
• Est. completion date: July 27, 2017

Study information

• Verified date: September 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 27, 2017
• Est. primary completion date: July 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
France	Orthopedic Surgery Department, University Hospital, Grenoble	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology Network, TIMC-IMAG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Description: Clinical Investigation Centre for Innovative Technology Network website