Knee OsteoarthritisMULTICARTNCT03210584
Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint
An observational study of Knee Osteoarthritis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Evaluation and comparison of histological analysis, 9,4 tesla MRI, Full-Field Optical Coherence Tomography (FFOCT) and ultrasound-based navigation system for cartilage degeneration analysis of patellofemoral joint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Sep 2018
- 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 arthroplasty indication for medial femoro-tibial osteoarthristis at University Hospital, Grenoble
Who may be able to join
- Over 18 years of age
- Knee prosthetic surgery indication with cartilage excision.
Who cannot join
- Subjects who refuse to sign a non-objection form
Trial locations and contacts
1 site in 1 country.
France1 site
Orthopedic Surgery Department, University Grenoble Hospital
Grenoble, 38043
About this study
Evaluation and comparison of histological analysis, 9,4 tesla MRI, Full-Field Optical Coherence Tomography (FFOCT) and ultrasound-based navigation system for cartilage degeneration analysis of patellofemoral joint.
Read the detailed description
Knee osteoarthritis (OA) is a common and debilitating chronic degenerative disease of the articular cartilage. Despite recent progress in the field of cartilage imaging, no routinely used clinical imaging modality has the ability to evaluate and monitor changes in cartilage degeneration. This observationnal, pilot, prospective, non randomized, uncontrolled, monocentric study aim to compare three of the most innovative imaging systems, namely the 9,4 Tesla MRI, the FFOCT (Full-Field Optical Coherence Tomography) and the ultrasound-based navigation system in order to image healthly to severely degraded human cartilage samples. All methods will be cross-correlated and compared with histological data considered as the gold standard.
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee joint, Cartilage degeneration, Ultrasound imaging, Full-Field Optical Coherence Tomography, 9,4 Tesla MRI, Multimodal evaluation
- Medical subject headings
- Osteoarthritis, Knee
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 |
|---|---|---|
| Imaging measurements | All subject of the study have a knee osteoarthritis (OA) and are going to have a knee prosthetic surgery with cartilage excision. Multimodal evaluation is conducted on ex vivo human cartilage samples (2 samples per patient are selected : healthy and severely degraded). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation and comparison of histologic analysis, 9,4 Tesla MRI, FFOCT and ultrasound-based navigation system for cartilage lesions analysis of patellofemoral joint.
Correlation between Osteoarthritis Research Society International (OARSI) grades performed for different modalities
Measured: 6 months
Secondary outcomes (9)
Evaluation of 9,4 Tesla MRI reconstructions in early osteoarthritis evaluation using visual qualitative information parameter obtained from the Average Pathlength Maps (APM).
Correlation between MRI quantitative parameters and gold standard OARSI grade
Measured: 6 months
Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual qualitative information parameter.
Correlation between quantitative parameters from FFOCT and gold standard OARSI grade
Measured: 6 months
Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual qualitative information parameter.
Correlation between quantitative parameters from navigation ultrasound and gold standard OARSI grade
Measured: 6 months
Evaluation of of 9,4 Tesla MRI reconstruction in early osteoarthritis evaluation using visual quantitative information parameter obtained for the Average Pathlength Maps.
Correlation between quantitative parameters from the Average Pathlength Maps and gold standard OARSI grade
Measured: 6 months
Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter.
Thickness average of cartilage
Measured: 6 months
Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter.
Roughness average of cartilage
Measured: 6 months
Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual quantitative information parameter.
Thickness average of cartilage
Measured: 6 months
Inter-observer robustness analysis of the OARSI classification
Inter-observers Kappa coefficient
Measured: 6 months
Intra-observer robustness analysis of the OARSI classification
Intra-observers Kappa coefficient
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study startOct 2016
- Primary completionJan 2017
- Study completionSep 2018
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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210584
- Sponsor's protocol ID
- 38 RC16.213
- Acronym
- MULTICART
- Status last verified
- Sep 2018
- First submitted
- 6 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
- Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint
- ClinicalTrials.gov ID
- NCT03210584
- Acronym / sponsor ID
- MULTICART / 38 RC16.213
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee joint, Cartilage degeneration, Ultrasound imaging, Full-Field Optical Coherence Tomography, 9,4 Tesla MRI, Multimodal evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 7 Jul 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.
Evaluation and comparison of histological analysis, 9,4 tesla MRI, Full-Field Optical Coherence Tomography (FFOCT) and ultrasound-based navigation system for cartilage degeneration analysis of patellofemoral joint.
Detailed description
Knee osteoarthritis (OA) is a common and debilitating chronic degenerative disease of the articular cartilage. Despite recent progress in the field of cartilage imaging, no routinely used clinical imaging modality has the ability to evaluate and monitor changes in cartilage degeneration. This observationnal, pilot, prospective, non randomized, uncontrolled, monocentric study aim to compare three of the most innovative imaging systems, namely the 9,4 Tesla MRI, the FFOCT (Full-Field Optical Coherence Tomography) and the ultrasound-based navigation system in order to image healthly to severely degraded human cartilage samples. All methods will be cross-correlated and compared with histological data considered as the gold standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging measurements | – | –All subject of the study have a knee osteoarthritis (OA) and are going to have a knee prosthetic surgery with cartilage excision. Multimodal evaluation is conducted on ex vivo human cartilage samples (2 samples per patient are selected : healthy and severely degraded). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with knee arthroplasty indication for medial femoro-tibial osteoarthristis at University Hospital, Grenoble
Key inclusion criteria (2 listed)
- Over 18 years of age
- Knee prosthetic surgery indication with cartilage excision.
Key exclusion criteria (1 listed)
- Subjects who refuse to sign a non-objection form
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 and comparison of histologic analysis, 9,4 Tesla MRI, FFOCT and ultrasound-based navigation system for cartilage lesions analysis of patellofemoral joint.
Time frame: 6 months
Correlation between Osteoarthritis Research Society International (OARSI) grades performed for different modalities
9 secondary outcomes
Evaluation of 9,4 Tesla MRI reconstructions in early osteoarthritis evaluation using visual qualitative information parameter obtained from the Average Pathlength Maps (APM).
Time frame: 6 months
Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual qualitative information parameter.
Time frame: 6 months
Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual qualitative information parameter.
Time frame: 6 months
Evaluation of of 9,4 Tesla MRI reconstruction in early osteoarthritis evaluation using visual quantitative information parameter obtained for the Average Pathlength Maps.
Time frame: 6 months
Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter.
Time frame: 6 months
Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter.
Time frame: 6 months
Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual quantitative information parameter.
Time frame: 6 months
Inter-observer robustness analysis of the OARSI classification
Time frame: 6 months
Intra-observer robustness analysis of the OARSI classification
Time frame: 6 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.
- 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
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 2 inclusion and 1 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 and comparison of histologic analysis, 9,4 Tesla MRI, FFOCT and ultrasound-based navigation system for cartilage lesions analysis of patellofemoral joint. (time frame: 6 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.