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Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint (MULTICART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210584
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Clinical Investigation Centre for Innovative Technology Network
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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.

Condition or disease
Knee Osteoarthritis

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.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint
Actual Study Start Date : October 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Group/Cohort
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).



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Correlation between MRI quantitative parameters and gold standard OARSI grade

  2. Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual qualitative information parameter. [ Time Frame: 6 months ]
    Correlation between quantitative parameters from FFOCT and gold standard OARSI grade

  3. Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual qualitative information parameter. [ Time Frame: 6 months ]
    Correlation between quantitative parameters from navigation ultrasound and gold standard OARSI grade

  4. 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 ]
    Correlation between quantitative parameters from the Average Pathlength Maps and gold standard OARSI grade

  5. Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter. [ Time Frame: 6 months ]
    Thickness average of cartilage

  6. Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter. [ Time Frame: 6 months ]
    Roughness average of cartilage

  7. Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual quantitative information parameter. [ Time Frame: 6 months ]
    Thickness average of cartilage

  8. Inter-observer robustness analysis of the OARSI classification [ Time Frame: 6 months ]
    Inter-observers Kappa coefficient

  9. Intra-observer robustness analysis of the OARSI classification [ Time Frame: 6 months ]
    Intra-observers Kappa coefficient


Biospecimen Retention:   None Retained
cartilage samples undergoing total knee arthroplasty procedure


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with knee arthroplasty indication for medial femoro-tibial osteoarthristis at University Hospital, Grenoble
Criteria

Inclusion Criteria:

  • Over 18 years of age
  • Knee prosthetic surgery indication with cartilage excision.

Exclusion Criteria:

  • Subjects who refuse to sign a non-objection form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210584


Locations
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France
Orthopedic Surgery Department, University Grenoble Hospital
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Clinical Investigation Centre for Innovative Technology Network
Investigators
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Principal Investigator: Alexandre Moreau-Gaudry, MD, PhD Clinical Investigation Centre for Innovative Technology Network
Additional Information:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03210584    
Other Study ID Numbers: 38 RC16.213
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
Knee joint
Cartilage degeneration
Ultrasound imaging
Full-Field Optical Coherence Tomography
9,4 Tesla MRI
Multimodal evaluation
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases