Clinical trial NCT03210584: Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint
Official title: Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: Knee joint
Cartilage degeneration
Ultrasound imaging
Full-Field Optical Coherence Tomography
9,4 Tesla MRI
Multimodal evaluation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2017-07-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with knee arthroplasty indication for medial femoro-tibial osteoarthristis at 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.

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

Primary outcomes:
measure: Evaluation and comparison of histologic analysis, 9,4 Tesla MRI, FFOCT and ultrasound-based navigation system for cartilage lesions analysis of patellofemoral joint.
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of 9,4 Tesla MRI reconstructions in early osteoarthritis evaluation using visual qualitative information parameter obtained from the Average Pathlength Maps (APM).
timeFrame: 6 months
measure: Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual qualitative information parameter.
timeFrame: 6 months
measure: Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual qualitative information parameter.
timeFrame: 6 months
measure: Evaluation of of 9,4 Tesla MRI reconstruction in early osteoarthritis evaluation using visual quantitative information parameter obtained for the Average Pathlength Maps.
timeFrame: 6 months
measure: Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter.
timeFrame: 6 months
measure: Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter.
timeFrame: 6 months
measure: Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual quantitative information parameter.
timeFrame: 6 months
measure: Inter-observer robustness analysis of the OARSI classification
timeFrame: 6 months
measure: Intra-observer robustness analysis of the OARSI classification
timeFrame: 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Orthopedic Surgery Department, University Grenoble Hospital
Study officials:
affiliation: Clinical Investigation Centre for Innovative Technology Network
name: Alexandre Moreau-Gaudry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: