'Delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) as an outcome measure to evaluate the effectiveness of intra-articular hyaluronic acid for knee osteoarthritis'

Phase 4

Completed

• Conditions: arthrosis; 10023213; multifactorial chronic joint disease

• Registration Number: NL-OMON34935
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Inclusion criteria are: knee pain for more than 3 months, with a severity of the knee pain of more than 2 mm on a VAS score (range 0 to 10 mm), and radiographic signs of knee OA, defined by a Kellgren & Lawrence score of grade 1 or 2.

Exclusion Criteria

viscosupplementation in the target knee within the last year, glucocorticoid or steroid injection into the target knee within the last three months, intra-articular procedure (arthroscopy (< 6 months), lavage, tibial osteotomy) within the last year, history of synovectomy, knee surgery scheduled within the next 4-5 months, dermatologic disorders or skin infection in proximity to the target knee, pregnant or planning to be pregnant or lactating females, poor general health status or specific condition that would interfere with functional assessments (bed ridden patients or patients in wheelchair or who are unable to walk 50 steps unaided), inflammatory arthritis, varus or valgus deformity > 12 degrees, chondrocalcinosis, presence of hip OA severe enough to affect the evaluation of function, receiving regular analgesic therapy for reasons other than painful OA of the knee, chronic use of daily (oral) steroid therapy, alcoholism, patients from whom it is not sure that they will be able to attend the follow-up measurements, insufficient command of the Dutch language, spoken and/or written,
Absolute and relative contra-indications for 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, metallic implant in the region of the target knee joint, pregnancy, lactating women, renal insuffiency (defined by a glomerular filtration rate of <60 milliliter/minute), allergy to contrast media

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change of dGEMRIC index</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the relationship between dGEMRIC changes and clinical changes 4<br /><br>months after intra-articular injection of hyaluronic acid in patients with knee<br /><br>osteoarthritis.</p><br>