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Completed

NCT Number: NCT03210584

Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopedic Surgery Department, University Grenoble Hospital

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Clinical Investigation Centre for Innovative Technology Network

Registry information

Acronym: MULTICART

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 7, 2017
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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