Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint

NCT ID: NCT03210584

Last Updated: 2018-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Investigation Centre for Innovative Technology Network

NETWORK

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre Moreau-Gaudry, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Investigation Centre for Innovative Technology Network

Locations

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Orthopedic Surgery Department, University Grenoble Hospital

Grenoble, , France

Site Status

Countries

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France

Related Links

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http://www.cic-it.fr/cic-it-grenoble.php

Clinical Investigation Centre for Innovative Technology Network website

Other Identifiers

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38 RC16.213

Identifier Type: -

Identifier Source: org_study_id

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