osteoarthritis of the knee
Conditions
Interventions
Product Name: Hylan G-F 20 (SynviscÒ, Genzyme Corp, Cambridge, MA)
Pharmaceutical Form: Solution for injection
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: knee pain needs to be present longer than 3 months, severity of the knee pain needs to be more than 2 mm on a VAS score, and radiographic signs of knee OA needs to be present, defined by a Kellgren & Lawrence score of grade 1 to 3. 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether there is a clinical relevant effect over a period of 12 months of intra-articular injections with high-molecular-weight HA competed to usual treatment in patients with osteoarthritis of the knee in secondary care (The usual care consists of exercise therapy according to the Dutch physiotherapy guidelines and/or pain medication with acetaminophen and/or NSAIDs). ;Secondary Objective: To assess whether there is cost-effectiveness over a period of 12 months of additive intra-articular injections with high-molecular-weight HA to usual care treatment in patients with osteoarthritis of the knee in secondary care. ;Primary end point(s): Difference in percentage of responders as defined by OMERACT-OARSI (improvement of minimally 20% in at least 2 of the 3 following domains; pain, function, patient’s global assessment) after 12 months of follow-up. | — |
Countries
Netherlands
Outcome results
None listed