Knee OsteoarthritisTRACTILAGENCT03181425
Magnetic Resonance Imaging Diffusion Tensor Tractography for Early Osteoarthritis Assessment
An observational study of Knee Osteoarthritis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aim of this study is the evaluation of new MRI tractography maps for early knee osteoarthritis assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Jun 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 arthoplasty indication
Who may be able to join
- Over 18 years of age Knee prosthetic surgery indication with cartilage excision
Who cannot join
- Refusal to sign a non-objection form
Trial locations and contacts
1 site in 1 country.
France1 site
Orthopedic Surgery Department, University Hopital Grenoble Alpes
Grenoble, 38043
About this study
Official title: Evaluation of Magnetic Resonance Imaging Diffusion Tensor and Knee Cartilage Tractography Reconstructions for the Study of Early Osteoarthritis
The aim of this study is the evaluation of new MRI tractography maps for early knee osteoarthritis assessment.
Read the detailed description
Knee osteoarthritis (OA) is a common and 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.
More and more studies report the benefits of Magnetic Resonance (MR) diffusion tensor imaging (DTI) in the study of early knee osteoarthritis and in particular the new MRI contrasts generating the Track Weighted Imaging (TWI) technique.
This observationnal, pilot, prospective, unrandomized and uncontrolled study aim to evaluate, for the first time, the new MRI tractography maps for the assessment of early knee osteoarthritis. This study doesn't modify the medical care of the patient.
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee cartilage, Early Osteoarthritis, MRI tractography, Diffusion Tensor Imaging
- 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 |
|---|---|---|
| Imaging assessment | All subject of the study have a knee osteoarthritis (OA) and are going to have a knee prosthetic surgery with cartilage excision. Imaging measurements are conducted on 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 of the MRI tractography reconstructions in the assessment of early osteoarthritis using the quantitative parameter of the average fiber lenght per voxel within a region of interest obtained from Average Pathlength Maps (APM).
Correlation between the average fiber lenght per voxel within a region of interest (APM maps) obtained from MRI tractography reconstructions of human cartilage and the gold standard of the arthrosis grade(OARSI).
Measured: 6 months
Secondary outcomes (7)
Evaluation of the MRI tractography reconstructions in the assessment of early osteoarthritis using a qualitative parameter of visual information obtained from APM maps.
Correlation between the qualitative parameter of visual information (heterogeneity, contrast density by fiber density) and the gold standard of the arthrosis grade(OARSI).
Measured: 6 months
Evaluation the of the MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted - Apparent Diffusion Coefficient (TW-ADC) obtained from APM maps
Correlation between the Track Weighted - Apparent Diffusion Coefficient (TW-ADC) and the gold standard of arthrosis grade (OARSI).
Measured: 6 months
Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted-Anisotropy Fraction (TW-FA) obtained from APM maps.
Correlation between the Track Weighted-Anisotropy Fraction (TW-FA) and the gold standard of arthrosis grade (OARSI).
Measured: 6 months
Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted -Fibre Orientation Distribution (TW-FOD) obtained from APM maps.
Correlation between the Track Weighted -Fibre Orientation Distribution (TW-FOD) and the gold standard of arthrosis grade (OARSI).
Measured: 6 months
Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis by using the Apparent Fibre Density (AFD) obtained from APM maps.
Correlation between the Apparent Fibre Density (AFD) and the gold standard of arthrosis grade (OARSI).
Measured: 6 months
Evaluation of Optical Coherence Tomography (OCT) in the assessment of early osteoarthritis.
Correlation between the qualitative parameter from OCT and the gold standard of arthrosis grade (OARSI).
Measured: 6 months
Sub-group analysis, according to the selected Anisotropy Fraction (FA) cutoff, to assess the MRI tractography reconstructions in the assessment of early osteoarthritis.
Correlation between the quantitative parameters previously cited and the gold standard of arthrosis grade (OARSI) for each group of Anisotropy Fraction (FA).
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 posted8 Jun 2017
- Study startOct 2016
- Primary completionApr 2017
- Study completionJun 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
- 8 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, University Hopital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181425
- Sponsor's protocol ID
- DCIC1614
- Acronym
- TRACTILAGE
- Status last verified
- Jul 2017
- First submitted
- 6 Jun 2017
- Last updated
- 6 Jul 2017
- 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 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Magnetic Resonance Imaging Diffusion Tensor and Knee Cartilage Tractography Reconstructions for the Study of Early Osteoarthritis
- ClinicalTrials.gov ID
- NCT03181425
- Acronym / sponsor ID
- TRACTILAGE / DCIC1614
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee cartilage, Early Osteoarthritis, MRI tractography, Diffusion Tensor Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 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
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 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.
The aim of this study is the evaluation of new MRI tractography maps for early knee osteoarthritis assessment.
Detailed description
Knee osteoarthritis (OA) is a common and 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.
More and more studies report the benefits of Magnetic Resonance (MR) diffusion tensor imaging (DTI) in the study of early knee osteoarthritis and in particular the new MRI contrasts generating the Track Weighted Imaging (TWI) technique.
This observationnal, pilot, prospective, unrandomized and uncontrolled study aim to evaluate, for the first time, the new MRI tractography maps for the assessment of early knee osteoarthritis. 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 |
|---|---|---|
| Imaging assessment | – | –All subject of the study have a knee osteoarthritis (OA) and are going to have a knee prosthetic surgery with cartilage excision. Imaging measurements are conducted on 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 arthoplasty indication
Key inclusion criteria (1 listed)
- Over 18 years of age Knee prosthetic surgery indication with cartilage excision
Key exclusion criteria (1 listed)
- Refusal 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 of the MRI tractography reconstructions in the assessment of early osteoarthritis using the quantitative parameter of the average fiber lenght per voxel within a region of interest obtained from Average Pathlength Maps (APM).
Time frame: 6 months
Correlation between the average fiber lenght per voxel within a region of interest (APM maps) obtained from MRI tractography reconstructions of human cartilage and the gold standard of the arthrosis grade(OARSI).
7 secondary outcomes
Evaluation of the MRI tractography reconstructions in the assessment of early osteoarthritis using a qualitative parameter of visual information obtained from APM maps.
Time frame: 6 months
Evaluation the of the MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted - Apparent Diffusion Coefficient (TW-ADC) obtained from APM maps
Time frame: 6 months
Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted-Anisotropy Fraction (TW-FA) obtained from APM maps.
Time frame: 6 months
Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted -Fibre Orientation Distribution (TW-FOD) obtained from APM maps.
Time frame: 6 months
Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis by using the Apparent Fibre Density (AFD) obtained from APM maps.
Time frame: 6 months
Evaluation of Optical Coherence Tomography (OCT) in the assessment of early osteoarthritis.
Time frame: 6 months
Sub-group analysis, according to the selected Anisotropy Fraction (FA) cutoff, to assess the MRI tractography reconstructions in the assessment of early osteoarthritis.
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 6 Jul 2017.
- 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 Hopital, 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 1 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 6 Jul 2017. 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 MRI tractography reconstructions in the assessment of early osteoarthritis using the quantitative parameter of the average fiber lenght per voxel within a region of interest obtained from Average Pathlength Maps (APM). (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 6 Jul 2017.