Evaluation of Patients With Knee Osteoarthritis Receiving a Prosthesis

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Patients with knee osteoarthritis, classified Kellgren-Lawrence 3 or 4, with asymmetric femorotibial joint space narrowing, that need a knee prosthesis

About this study

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

Conditions

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

Being tested

Clinical evaluation, Radiology, Dynamic contrast-enhanced magnetic resonance imaging, Evaluation of histological status

Keywords

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

Medical subject headings

Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Clinical evaluationDiagnostic test

  Functional scores for the pathological joint will be determined

• RadiologyDiagnostic test

• Dynamic contrast-enhanced magnetic resonance imagingDiagnostic 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 statusDiagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

   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.

   Measured: At inclusion

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

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

   Measured: At inclusion

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

   Measured: 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

   Measured: 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

   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.

   Measured: At inclusion

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

   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.

   Measured: through study completion, an average of 3 years

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

   Analysis of the surgical section

   Measured: through study completion, an average of 3 years

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

   Analysis of the surgical section

   Measured: through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted23 Aug 2018
2. Study startMay 2013
3. Primary completionApr 2016
4. Study completionDec 2016

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.