Abstract | INTRODUCTION: MATERIALS AND METHODS: Pilot, prospective, multi-centre, open-label, randomised trial in 100 patients with unilateral, symptomatic, tibio-femoral OA (Kellgren-Lawrence grade II or III), aged > or =40 years. Patients were randomised to receive varying dosing regimens of hylan G-F 20 (1 x 6 mL, 1 x 4 mL, 2 x 4 mL 2 weeks apart, 3 x 4 mL 1 week apart, or 3 x 2 mL 1 week apart). Adverse events (AE's) were monitored throughout the study. The primary efficacy endpoint was the change from baseline in the patient-rated knee OA pain assessment (100 mm visual analogue scale (VAS)) at 24 weeks. The secondary efficacy criteria included the WOMAC index, patient and physician global assessments using a 100 mm VAS, and knee OA pain assessment at all other visits. Concomitant use of permitted rescue medications ( paracetamol) was also assessed. RESULTS: The treatment was well tolerated overall. Patients in the 3 x 4 mL group reported the highest percentage of device-related local AE's (30%) while patients in the 1 x 6 mL and 3 x 2 mL groups reported only 10%. There were no serious device-related AEs. There was a statistically significant improvement from baseline at week 24 in all efficacy endpoints for all treatment regimens. The 1 x 6 and 3 x 4 and 3 x 2 mL treatment groups showed the greatest mean improvements (-34.9, -32.6 and -36.7 mm respectively) in the patient-rated knee OA pain assessment VAS. CONCLUSION: This study suggests that a single 6 mL injection of hylan G-F 20 may be as efficacious, and as well tolerated, as 3 x 2 mL one week apart. A double-blind, controlled trial is needed to confirm these data.
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Authors | T Conrozier, J Jerosch, P Beks, F Kemper, L Euller-Ziegler, F Bailleul, X Chevalier |
Journal | Archives of orthopaedic and trauma surgery
(Arch Orthop Trauma Surg)
Vol. 129
Issue 3
Pg. 417-23
(Mar 2009)
ISSN: 1434-3916 [Electronic] Germany |
PMID | 18365224
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Biocompatible Materials
- hylan
- Hyaluronic Acid
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Arthralgia
(drug therapy, etiology)
- Biocompatible Materials
(administration & dosage)
- Dose-Response Relationship, Drug
- Female
- Humans
- Hyaluronic Acid
(administration & dosage, analogs & derivatives)
- Injections, Intra-Articular
- Male
- Middle Aged
- Osteoarthritis, Knee
(complications, drug therapy)
- Pilot Projects
- Prospective Studies
- Treatment Outcome
- Viscosupplementation
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