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NCT03210584 Clinical Trial

Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint

Knee Osteoarthritis Clinical Trial

— MULTICART  

Official title:
Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03210584
Other study ID # 38 RC16.213
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2016
Est. completion date September 2018

Study information
Verified date September 2018
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date September 2018
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Orthopedic Surgery Department, University Grenoble Hospital Grenoble

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Grenoble Clinical Investigation Centre for Innovative Technology Network

Country where clinical trial is conducted

France, 

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