Validation of four quantitative radiological techniques to image cartilage quality in patients with knee osteoarthritis scheduled to undergo total knee replacement.

Completed

• Conditions: knee osteoarthritis; knee wear; 10023213

• Registration Number: NL-OMON37160
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Patient is older than 18 years, knee pain for more than one month, a discrepancy in radiological OA stage between both compartments of the tibiofemoral joint (one compartment severe and one compartment mild to moderate OA according to Kellgren & Lawrence, and one of the following: patient is older than 38 years, there is less than 30 minutes of morning stiffness in the knee or crepitures and bony enlargement are present during physical examination.

Exclusion Criteria

Severe knee OA without asymmetric distribution in severity between both compartments of the tibiofemoral joint, varus or valgus deformity in the knee > 10 degrees, chondrocalcinosis, absolute and relative contra-indications to undergo MRI: brain aneurysm clip, implanted neural stimulator, cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body, other implanted medical devices: (e.g. catheters, insulin pump, metal shrapnel or bullet or metallic implant in the region of the target knee joint), pregnancy, lactating women, renal insufficiency (defined by a glomerular filtration rate of <60 milliliter/minute), allergy to contrast agents for dGEMRIC or CTa (Magnevist ®, Bayer Schering AG, Berlin, Germany or Hexabrix 320, Mallinckrodt, Hazelwood, MO, USA), alcoholism or insufficient command of the Dutch language: spoken and/or written.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoints in this study are the correlation coefficients between the<br /><br>in vivo outcomes of the quantitative MRI and CT techniques under investigation<br /><br>and the in vitro reference standards for cartilage sGAG and collagen content.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint of this study is the relation between the outcomes of<br /><br>the DCE-MRI and the outcomes of the WOMAC and ICOAP questionnaires.</p><br>