Clinical trial NCT03644420: Evaluation of Patients With Knee Osteoarthritis Receiving a Prosthesis
Official title: Association Between Preoperative Clinical Evaluation, Radiological Classifications and Histopathology in Patients With Knee Osteoarthritis Receiving a Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Perfusion
Bone Marrow
Magnetic Resonance Imaging
Keywords: Osteoarthritis
Knee
Bone
Bone Marrow
Magnetic Resonance Imaging
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Institut de Prévention et de Recherche sur l'Ostéoporose
First posted: 2018-08-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with knee osteoarthritis, classified Kellgren-Lawrence 3 or 4, with asymmetric femorotibial joint space narrowing, that need a knee prosthesis

Brief summary: Patients with osteoarthritis of the knee undergo visible joint changes in radiology and Magnetic resonance imaging (MRI) tests, but also clinically and histologically. The area of greatest change is at the subchondral/cartilage bone junction.

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.


Eligibility criteria: Inclusion Criteria:

* Patients with knee osteoarthritis, classified Kellgren-Lawrence 3 or 4, with asymmetric femorotibial joint space narrowing
* Patients requiring a total knee prosthesis

Exclusion Criteria:

* Patients with a known progressive inflammatory pathology (rheumatoid arthritis,...).
* 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.

Primary outcomes:
measure: Score IKDC (International Knee Documentation Committee) for functional evaluation of the articulation
timeFrame: At inclusion
measure: Score WOMAC (Western Ontario McMaster University ) for functional evaluation of the articulation
timeFrame: At inclusion
measure: Radiographic assesment of osteoarthritis according to absence/presence of pathology
timeFrame: At inclusion
measure: Assesment of subchondral bone marrow vascularization by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) according to the % Area Under the Curve (AUC) of perfusion value
timeFrame: At inclusion
measure: The magnetic resonance imaging -based Whole-Organ Magnetic Resonance Imaging (WORMS) Score to assess the full spectrum of knee structures and the severity of knee pathologies
timeFrame: At inclusion
measure: Analysis of the surgical section by the OARSI score (Osteoarthritis research society international) for evaluation of histologic status
timeFrame: through study completion, an average of 3 years
measure: Osteoarthritis pathology assessment according to the number of vessels in the subchondral bone
timeFrame: through study completion, an average of 3 years
measure: Osteoarthritis pathology assessment according to the thickness of the subchondral bone
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Raphael Coursier, MD
role: PRINCIPAL_INVESTIGATOR
References: