Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint

Completed

• Conditions: Knee Osteoarthritis

• Registration Number: NCT03210584
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-10
• Primary Completion: 2017-01
• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-07
• Status Verified: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation and comparison of histologic analysis, 9,4 Tesla MRI, FFOCT and ultrasound-based navigation system for cartilage lesions analysis of patellofemoral joint.	6 months	Correlation between Osteoarthritis Research Society International (OARSI) grades performed for different modalities

Secondary Outcome Measures

Name	Time	Method
Intra-observer robustness analysis of the OARSI classification	6 months	Intra-observers Kappa coefficient
Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual qualitative information parameter.	6 months	Correlation between quantitative parameters from FFOCT and gold standard OARSI grade
Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual qualitative information parameter.	6 months	Correlation between quantitative parameters from navigation ultrasound and gold standard OARSI grade
Inter-observer robustness analysis of the OARSI classification	6 months	Inter-observers Kappa coefficient
Evaluation of 9,4 Tesla MRI reconstructions in early osteoarthritis evaluation using visual qualitative information parameter obtained from the Average Pathlength Maps (APM).	6 months	Correlation between MRI quantitative parameters and gold standard OARSI grade
Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter.	6 months	Roughness average of cartilage
Evaluation of of 9,4 Tesla MRI reconstruction in early osteoarthritis evaluation using visual quantitative information parameter obtained for the Average Pathlength Maps.	6 months	Correlation between quantitative parameters from the Average Pathlength Maps and gold standard OARSI grade
Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual quantitative information parameter.	6 months	Thickness average of cartilage

Trial Locations

Locations (1)

Orthopedic Surgery Department, University Grenoble Hospital; 🇫🇷 Grenoble, France