Osteoarthritis of the knee
Conditions
Interventions
Product Name: Hylan G-F 20 (Synvisc, Genzyme Corp, Cambridge, MA
Product Code: 4001387
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the pla
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria are: 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 ( 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the feasibility of dGEMRIC for detecting cartilage changes 3-4 months after intra-articular injection of hyaluronic acid in patients with knee osteoarthritis.;Secondary Objective: To assess the relationship between dGEMRIC changes and clinical changes 3-4 months after intra-articular injection of hyaluronic acid in patients with knee osteoarthritis.;Primary end point(s): Difference in percentage of responders as defined by OMERACT-OARSI (improvement of ? 20% in at least 2 of the 3 following domains; pain, function, patient’s global assessment) (23) after 3-4 months of follow-up. | — |
Countries
Netherlands
Outcome results
None listed