Skip to main content
OpenTrials
Completed

NCT Number: NCT03644420

Evaluation of Patients With Knee Osteoarthritis Receiving a Prosthesis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Knee Arthritis Bone Marrow Joint Diseases Magnetic Resonance Imaging Musculoskeletal Diseases Osteoarthritis Perfusion Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical evaluation

Diagnostic Test

Functional scores for the pathological joint will be determined

Radiology

Diagnostic Test

Dynamic contrast-enhanced magnetic resonance imaging

Diagnostic Test

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

Diagnostic Test

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

Primary outcomes

  1. Score IKDC (International Knee Documentation Committee) for functional evaluation of the articulation

    Time frame: At inclusion

    The 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.

  2. Score WOMAC (Western Ontario McMaster University ) for functional evaluation of the articulation

    Time frame: At inclusion

    An arthritic pain scoring system ranging from 0-no pain/disability to 100-most severe pain/disability

  3. Radiographic assesment of osteoarthritis according to absence/presence of pathology

    Time frame: At inclusion

  4. 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

    Time frame: At inclusion

  5. 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

    Time frame: At inclusion

    WORMS 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.

  6. Analysis of the surgical section by the OARSI score (Osteoarthritis research society international) for evaluation of histologic status

    Time frame: through study completion, an average of 3 years

    The 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.

  7. Osteoarthritis pathology assessment according to the number of vessels in the subchondral bone

    Time frame: through study completion, an average of 3 years

    Analysis of the surgical section

  8. Osteoarthritis pathology assessment according to the thickness of the subchondral bone

    Time frame: through study completion, an average of 3 years

    Analysis of the surgical section

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • Institut de Prévention et de Recherche sur l'Ostéoporose

Registry information

Official study title

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

Acronym: Chondrolike

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 23, 2018
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.