Evaluation of Patients With Knee Osteoarthritis Receiving a Prosthesis
NCT ID: NCT03644420
Last Updated: 2018-08-23
Study Results
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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COMPLETED
22 participants
OBSERVATIONAL
2013-05-31
2016-12-31
Brief Summary
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Investigators will determine the association between preoperative clinical evaluation (IKDC and Womac scores), radiological classifications and histopathology.
In addition, the role of inflammation in the pathogenesis of osteoarthritis is being given major interest, and inflammation is closely linked with vascularization. It was recently demonstrated that dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) could identify the subchondral bone marrow vascularization changes occurring in osteoarthritis in animals.
These changes appeared before cartilage lesions were visible and were correlated with osteoarthritis severity. Thus the opportunity to obtain an objective assessment of bone vascularization in non-invasive conditions in humans might help better understanding osteoarthritis pathophysiology and finding new biomarkers. Investigators hypothesized that, as in animals, DCE-MRI has the ability to identify subchondral bone marrow vascularization changes in human osteoarthritis.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Knee osteoarthritis
Patients with knee osteoarthritis, classified Kellgren-Lawrence 3 or 4, with asymmetric femorotibial joint space narrowing that will follow a surgery for a prosthetic replacement of the knee wil follow the following interventions:
* Clinical evaluation
* Radiographic assessment of osteoarthritis
* Magnetic resonance imaging (MRI)
* Histological evaluation of the surgical piece
Dynamic contrast-enhanced magnetic resonance imaging
Patients will be examined using a 3T MR scanner (MR 750W, General Electrics, Milwaukee, WI) with a dedicated knee coil. Subchondral bone marrow vascularization in medial and lateral femorotibial compartments will be assessed with DCE-MRI and lesions will be graded on MR images.
Evaluation of histological status
Upper tibial resection pieces will be collected and the vascularization will be determined according to the OARSI score
Clinical evaluation
Functional scores for the pathological joint will be determined
Radiology
Interventions
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Dynamic contrast-enhanced magnetic resonance imaging
Patients will be examined using a 3T MR scanner (MR 750W, General Electrics, Milwaukee, WI) with a dedicated knee coil. Subchondral bone marrow vascularization in medial and lateral femorotibial compartments will be assessed with DCE-MRI and lesions will be graded on MR images.
Evaluation of histological status
Upper tibial resection pieces will be collected and the vascularization will be determined according to the OARSI score
Clinical evaluation
Functional scores for the pathological joint will be determined
Radiology
Eligibility Criteria
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Inclusion Criteria
* Patients requiring a total knee prosthesis
Exclusion Criteria
* Patients with previous surgery of the knee
* Contra-indication for magnetic resonance imaging, chronic renal failure (creatinine clearance \< 30 ml/min), contrast media allergy, orthopaedic hardware around the knee. Patients in whom motion artifacts impaired image analysis will be excluded.
18 Years
ALL
No
Sponsors
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Institut de Prévention et de Recherche sur l'Ostéoporose
UNKNOWN
Lille Catholic University
OTHER
Responsible Party
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Principal Investigators
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Raphael Coursier, MD
Role: PRINCIPAL_INVESTIGATOR
Groupement des Hôpitaux de l'Institut Catholique de Lille
Other Identifiers
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RT-07
Identifier Type: -
Identifier Source: org_study_id
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