To assess whether there is (cost) effectiveness over a period of 1 year of additive intra-articular injections with a high molecular HA derivate in patients with OA of the knee.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the difference in % of responders (improvement of ³ 20% in
at least 2 of the 3 domains; pain, function, patient*s global assessment) after
12 months of follow-up.
Secondary outcome
Difference in primary outcome parameter after 6 weeks, 3 and 6 months, in pain
severity, KOOS, and quality of life (EQ5D) after 6 weeks, 3, 6 and 12 months.
Also difference in side effects, medical consumption and costs (visits to
health care providers and consumptions of prescription or over the counter
medication), absence from work or decreased productivity at work, and patient
costs to be able to do cost-effectiveness analysis will be assessed.
Background summary
Osteoarthritis (OA) is the most frequent chronic joint disease causing pain and
disability of especially the knee. The usual choice of initial therapy in
patients with clinical knee OA is pain relief by Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs), if necessary combined with physical therapy.
Another treatment option in patients with clinical knee OA is
viscosupplementation (VS), which is reported by a Cochrane review to show good
clinical results on pain, function and patient global assessment even in the
long-term. Because of the lack of evidence of the cost-effectiveness of high
molecular HA products in the Netherlands, the use of HA is very limited which
may result in higher total costs of treatment than necessary.
Study objective
To assess whether there is (cost) effectiveness over a period of 1 year of
additive intra-articular injections with a high molecular HA derivate in
patients with OA of the knee.
Study design
Open-labeled randomized clinical trial.
Intervention
Intervention group; 3 injections with a high molecular HA derivate added to the
usual care treatment (UC), the control group; UC (exercise therapy and pain
medication).
Study burden and risks
The measurements needed for the data collection of the present study consist
of a standard X ray of the knee at baseline and questionnaires (30 minutes per
time). These measurements are standard care in case of patients with knee OA.
Only local reactions have been reported (transient and mild).
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
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.
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 9 months, dermatologic disorders or skin infection in proximity to the study 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-005814-28-NL |
| CCMO | NL24430.078.08 |