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Clinical Trials/NCT03210584
NCT03210584
Completed
Not Applicable

Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint

University Hospital, Grenoble1 site in 1 country10 target enrollmentOctober 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
University Hospital, Grenoble
Enrollment
10
Locations
1
Primary Endpoint
Evaluation and comparison of histologic analysis, 9,4 Tesla MRI, FFOCT and ultrasound-based navigation system for cartilage lesions analysis of patellofemoral joint.
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
September 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual qualitative information parameter.(6 months)
  • Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual qualitative information parameter.(6 months)
  • Inter-observer robustness analysis of the OARSI classification(6 months)
  • 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)
  • Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter.(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.(6 months)
  • Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual quantitative information parameter.(6 months)
  • Intra-observer robustness analysis of the OARSI classification(6 months)

Study Sites (1)

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