No registrations found.
ID
Source
Brief title
Health condition
osteoarthritis, knee; hyaluronic acid, cost-effectiveness,
Sponsors and support
Department of Orthopedics
J.A.N Verhaar, PhD MD, Head of the department
Intervention
Outcome measures
Primary outcome
Cost-effectiveness of 3 weekly intra-articular injections with a HA polymer added to usual care.
Secondary outcome
Effectiveness of 3 weekly intra-articular injections with HA polymer added to usual care. Subanalysis will be performed for severity of radiographic OA (Kellgren & Lawrence grade 1 and 2 versus grade 3).
Background summary
Assessment of cost-effectiveness and efectiveness of 3 weekly intra-articular injections with a HA polymer added to usual care in patients with clinical knee osteoartritis.
Study objective
1. Viscosupplementation therapy for patients with osteoarthritis of the knee is cost-effective for the dutch health care system;
2. Viscosupplementation therapy for patients with osteoarthritis of the knee has a clinical relevant effect competed to usual treatment.
Study design
6 wk, 3, 6, 9, 12 mnth
Intervention
Intra-articular injection with a high molecular weight chemically crosslinked hyaluronan polymer of avian origin (HA-polymer) will be given in total three times with a time interval of one week between injections (48 mg hyaluronate derivate per series), provided by a trained orthopedic surgeon according to a standardized protocol. This treatment with Hylan G-F 20 is added to the usual care treatment.
PO box 2040
M. Reijman
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4033642
m.reijman@erasmusmc.nl
PO box 2040
M. Reijman
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4033642
m.reijman@erasmusmc.nl
Inclusion criteria
1. Knee pain needs to be present longer than 3 months;
2. Severity of the knee pain needs to be more than 2 mm on a VAS score;
3. Radiographic signs of knee OA needs to be present defined by a Kellgren & Lawrence score of grade 1 to 3.
Exclusion criteria
1. Viscosupplementation in the target knee within the last year;
2. Glucocorticoid or steroid injection into the target knee within the last three months;
3. Intra-articular procedure (arthroscopy (< 6 months), lavage, tibial osteotomy) within the last year;
4. History of synovectomy;
5. Knee surgery scheduled within the next 9 months;
6. Dermatologic disorders or skin infection in proximity to the study knee;
7. Pregnant or planning to be pregnant or lactating females;
8. 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);
9. Inflammatory arthritis;
10. Varus or valgus deformity > 12 degrees;
11. Chondrocalcinosis;
12. Presence of hip OA severe enough to affect the evaluation of function;
13. Receiving regular analgesic therapy for reasons other than painful OA of the knee;
14. Chronic use of daily (oral) steroid therapy;
15. Alcoholism;
16. Patients from whom it is not sure that they will be able to attend the follow-up measurements;
17. Insufficient command of the Dutch language, spoken and/or written.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL1572 |
| NTR-old | NTR1651 |
| Other | MEC Erasmus MC : 2008-267 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |