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Evaluation of Patients With Knee Osteoarthritis Receiving a Prosthesis

Association Between Preoperative Clinical Evaluation, Radiological Classifications and Histopathology in Patients With Knee Osteoarthritis Receiving a Prosthesis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03644420
Acronym
Chondrolike
Enrollment
22
Registered
2018-08-23
Start date
2013-05-31
Completion date
2016-12-31
Last updated
2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow, Magnetic Resonance Imaging, Osteoarthritis, Knee, Perfusion

Keywords

Osteoarthritis, Knee, Bone, Bone Marrow, Magnetic Resonance Imaging

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.

Interventions

DIAGNOSTIC_TESTClinical evaluation

Functional scores for the pathological joint will be determined

DIAGNOSTIC_TESTRadiology
DIAGNOSTIC_TESTDynamic 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.

DIAGNOSTIC_TESTEvaluation of histological status

Upper tibial resection pieces will be collected and the vascularization will be determined according to the OARSI score

Sponsors

Institut de Prévention et de Recherche sur l'Ostéoporose
CollaboratorUNKNOWN
Lille Catholic University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Score IKDC (International Knee Documentation Committee) for functional evaluation of the articulationAt inclusionThe IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity subscale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks patients one simple question: how is their knee at present versus how was their knee prior to injury? Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Score WOMAC (Western Ontario McMaster University ) for functional evaluation of the articulationAt inclusionAn arthritic pain scoring system ranging from 0-no pain/disability to 100-most severe pain/disability
Radiographic assesment of osteoarthritis according to absence/presence of pathologyAt inclusion
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 valueAt inclusion
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 pathologiesAt inclusionWORMS scoring for cartilage. Cartilage lesions are scored with the WORMS system on an eight-point scale, as follows: 0 indicates normal cartilage; 1, increased signal with fluid-sensitive intermediate-weighted sequences; 2, partial-thickness defect less than 1 cm in greatest width; 2.5, full-thickness defect less than 1 cm in greatest width; 3, multiple areas of partial-thickness (grade 2) defects intermixed with areas of normal thickness or a partial-thickness defect wider than 1 cm but less than 75% of the region; 4, diffuse (≥75% of the region) partial-thickness loss; 5, multiple areas of full-thickness loss (grade 2.5) or a full-thickness defect wider than 1 cm but less than 75% of the region; and 6, diffuse (≥75% of the region) full-thickness loss.
Analysis of the surgical section by the OARSI score (Osteoarthritis research society international) for evaluation of histologic statusthrough study completion, an average of 3 yearsThe OARSI system is based on histologic features of osteoarthritis progression. The system employs analysis of a standard block/section assessment by grade, stage of arthritis with subsequent calculation of an arthritis score. With normal cartilage as grade 0, osteoarthritis severity is divided into six grades. Grades 1-4 involve articular cartilage changes only, whereas grades 5 and 6 involve subchondral bone as well.
Osteoarthritis pathology assessment according to the number of vessels in the subchondral bonethrough study completion, an average of 3 yearsAnalysis of the surgical section
Osteoarthritis pathology assessment according to the thickness of the subchondral bonethrough study completion, an average of 3 yearsAnalysis of the surgical section

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026