Knee OsteoarthritisCARTILAGENCT03184051
Diagnostic Performance of Ultrasound Imaging Technique for Femoral Condyle Cartilage Evaluation and Osteoarthritis
An observational study of Knee Osteoarthritis, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2017to 27 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with knee osteoarthritis with an indication of total arthroplasty
Who may be able to join
- patient over 18 year old
- knee osteoarthritis which total knee arthroplasty indication
- who have signed a non-objection form.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Orthopedic Surgery Department, University Hospital, Grenoble
Grenoble, 38043
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Ultrasonography evaluation/ultrasound, Articular cartilage, UltraSound Speed Of Sound (US-SOS), UltraSound Time of Flight (US-TOF)
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start15 Jun 2017
- Primary completion27 Jul 2017
- Study completion27 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- TIMC-IMAG, Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor
- Investigators
- Alexandre Moreau -Gaudry, MD, PhD, Principal investigator, Clinical Investigation Centre for Innovative Technology Network - University Hospital Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184051
- Sponsor's protocol ID
- 38RC17.074
- Acronym
- CARTILAGE
- Status last verified
- Sep 2018
- First submitted
- 8 Jun 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualification of Ultrasound Imaging Technique in the Quantitative Evaluation of Cartilaginous Tissue of Femoral Condyle Articulation and Osteoarthritis
- ClinicalTrials.gov ID
- NCT03184051
- Acronym / sponsor ID
- CARTILAGE / 38RC17.074
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Ultrasonography evaluation/ultrasound, Articular cartilage, UltraSound Speed Of Sound (US-SOS), UltraSound Time of Flight (US-TOF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- TIMC-IMAG, Clinical Investigation Centre for Innovative Technology Network
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with knee osteoarthritis with an indication of total arthroplasty
Key inclusion criteria (3 listed)
- patient over 18 year old
- knee osteoarthritis which total knee arthroplasty indication
- who have signed a non-objection form.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
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
Evaluation of correlation between thickness measured by MRI and this measured by histological analysis.
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Description: Clinical Investigation Centre for Innovative Technology Network websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Moreau -Gaudry, MD, PhD principal investigator
Clinical Investigation Centre for Innovative Technology Network - University Hospital Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.