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CompletedNCT03210584MULTICARTUpdated Sep 11, 2018

Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint

An observational study in Knee Osteoarthritis, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-11.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Knee joint
  • Cartilage degeneration
  • Ultrasound imaging
  • Full-Field Optical Coherence Tomography
  • 9,4 Tesla MRI
  • Multimodal evaluation
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In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's enrollment of 10 is below the median of 100 across 484 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with knee arthroplasty indication for medial femoro-tibial osteoarthristis at University Hospital, Grenoble

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Over 18 years of age
  • Knee prosthetic surgery indication with cartilage excision.

Exclusion criteria

Exclusion Criteria:

  • Subjects who refuse to sign a non-objection form
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • Imaging measurements

    All subject of the study have a knee osteoarthritis (OA) and are going to have a knee prosthetic surgery with cartilage excision. Multimodal evaluation is conducted on ex vivo human cartilage samples (2 samples per patient are selected : healthy and severely degraded).

06

What researchers measure

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.

    Correlation between Osteoarthritis Research Society International (OARSI) grades performed for different modalities

    Time frame: 6 months

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).

    Correlation between MRI quantitative parameters and gold standard OARSI grade

    Time frame: 6 months

  2. Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual qualitative information parameter.

    Correlation between quantitative parameters from FFOCT and gold standard OARSI grade

    Time frame: 6 months

  3. 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

    Time frame: 6 months

  4. 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

    Time frame: 6 months

  5. Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter.

    Thickness average of cartilage

    Time frame: 6 months

  6. Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter.

    Roughness average of cartilage

    Time frame: 6 months

  7. Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual quantitative information parameter.

    Thickness average of cartilage

    Time frame: 6 months

  8. Inter-observer robustness analysis of the OARSI classification

    Inter-observers Kappa coefficient

    Time frame: 6 months

  9. Intra-observer robustness analysis of the OARSI classification

    Intra-observers Kappa coefficient

    Time frame: 6 months

07

Study locations

1 site
  • Orthopedic Surgery Department, University Grenoble Hospital
    Grenoble, 38043, France
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03210584
Collaborators
Clinical Investigation Centre for Innovative Technology Network
Responsible party
Sponsor
First posted
Jul 7, 2017
Start date
Oct 2016
Primary completion
Jan 2017
Completion
Sep 2018
Last update
Sep 11, 2018

Study contacts

Alexandre Moreau-Gaudry, MD, PhD
principal investigator · Clinical Investigation Centre for Innovative Technology Network

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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