Evaluation of Patients With Knee Osteoarthritis Receiving a Prosthesis

Osteoarthritis, Knee Clinical Trial

— Chondrolike  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644420
• Other study ID #: RT-07
• Status: Completed
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: August 2018
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Clinical evaluation
Functional scores for the pathological joint will be determined
• Radiology

• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	Institut de Prévention et de Recherche sur l’Ostéoporose

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At inclusion
Primary	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	At inclusion
Primary	Radiographic assesment of osteoarthritis according to absence/presence of pathology		At inclusion
Primary	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		At inclusion
Primary	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.	At inclusion
Primary	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.	through study completion, an average of 3 years
Primary	Osteoarthritis pathology assessment according to the number of vessels in the subchondral bone	Analysis of the surgical section	through study completion, an average of 3 years
Primary	Osteoarthritis pathology assessment according to the thickness of the subchondral bone	Analysis of the surgical section	through study completion, an average of 3 years