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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26016
Enrollment
154
Registered
2009-03-03
Start date
2009-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthritis, knee

Interventions

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 betwee

Sponsors

Erasmus MC Department of Orthopedics J.A.N Verhaar, PhD MD, Head of the department
Lead Sponsor

Eligibility

Inclusion criteria

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

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 ( 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 outcomes

Primary

MeasureTime frame
Cost-effectiveness of 3 weekly intra-articular injections with a HA polymer added to usual care.

Secondary

MeasureTime frame
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).

Contacts

Public ContactM. Reijman

Department of Orthopedics PO box 2040

m.reijman@erasmusmc.nl+31 (0)10 4033642

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)