Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint

Conditions
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Knee Osteoarthritis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Imaging measurements<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 6 months | 
| Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter. | Thickness average of cartilage | 6 months | 
| Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter. | Roughness average of cartilage | 6 months | 
| Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual quantitative information parameter. | Thickness average of cartilage | 6 months | 
| Inter-observer robustness analysis of the OARSI classification | Inter-observers Kappa coefficient | 6 months | 
| Intra-observer robustness analysis of the OARSI classification | Intra-observers Kappa coefficient | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee joint, Cartilage degeneration, Ultrasound imaging, Full-Field Optical Coherence Tomography, 9,4 Tesla MRI, Multimodal evaluation