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Cost-effectiveness of viscosupplementation therapy for patients with osteoarthritis of the knee: a randomized clinical trial.


- candidate number5405
- NTR NumberNTR1651
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-mrt-2009
- Secondary IDs2008-267 MEC Erasmus MC
- Public TitleCost-effectiveness of viscosupplementation therapy for patients with osteoarthritis of the knee: a randomized clinical trial.
- Scientific TitleCost-effectiveness of viscosupplementation therapy for patients with osteoarthritis of the knee: a randomized clinical trial.
- ACRONYMVISK study
- hypothesis1. 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.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2009
- planned closingdate1-jan-2012
- Target number of participants154
- InterventionsIntra-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.
- Primary outcomeCost-effectiveness of 3 weekly intra-articular injections with a HA polymer added to usual care.
- Secondary outcomeEffectiveness 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).
- Timepoints6 wk, 3, 6, 9, 12 mnth
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD, senior researcher M. Reijman
- CONTACT for SCIENTIFIC QUERIESPhD, senior researcher M. Reijman
- Sponsor/Initiator Erasmus Medical Center, Department of Orthopaedics
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryAssessment 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.
- Main changes (audit trail)
- RECORD3-mrt-2009 - 14-sep-2009


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