Abstract
Introduction
Clinical trials have demonstrated the safety and efficacy of hyaluronic acid-based products for the treatment of hip osteoarthritis, but data from observational studies of normal medical practice are scarce. This study investigated the long-term efficacy and tolerability of ultrasound-guided intra-articular sodium hyaluronate (MW 1,500–2,000 kDa; Hyalone®) injections in daily clinical practice.
Methods
In this observational, cohort study of patients with hip osteoarthritis, Hyalone® was administered under the ultrasound guidance, every 6 months, with the possibility of an additional injection at the intervening 3-month intervals on clinical request. Efficacy measurements included the Lequesne algofunctional index, self-reported pain via the visual analogue scale (VAS), the concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) and safety. The patients were followed up for 18 months after the first intra-articular injection.
Results
Data from 120 patients were collected. During the study, a statistically significant reduction in algofunctional indexes was demonstrated at 3 months after study product injection, while at 12 months 80% of the patients achieved a decrease of at least 30% in symptoms. These results were maintained over time through cyclical and personalized repetition of ultrasound guided injections, at least one injection every 6 months.
Conclusions
The study treatment reduced pain and improved mobility in osteoarthritis of the hip. These results in daily clinical practice demonstrate a beneficial effect and the safety of the study product and suggest adding intra-articular injections of HyalOne® to the armamentarium of conservative management of symptomatic hip osteoarthritis.
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Abbreviations
- ACR:
-
American College of Rheumatology
- BMI:
-
Body mass index
- CI:
-
Confidence interval
- HA:
-
Hyaluronic acid
- IA:
-
Intra-articular
- NSAID:
-
Non-steroidal anti-inflammatory drug
- OA:
-
Osteoarthritis
- RCT:
-
Randomised controlled trial
- ROC:
-
Receiver operating characteristic
- US:
-
Ultrasound
- VAS:
-
Visual analogue scale
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Acknowledgements
Data collection and analysis, the reporting and writing of this study were supported by a grant from Fidia Farmaceutici S.p.A. No equipment or other supplies were provided by Fidia Farmaceutici S.p.A. The authors declare no conflict of interest with respect to the contents of this article.
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The authors declare that they have no competing interests.
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An erratum to this article can be found at http://dx.doi.org/10.1007/s00402-012-1491-x.
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Alberto, M., Umberto, M., Emanuele, B. et al. Intra-articular injection of hyaluronic acid (MW 1,500–2,000 kDa; HyalOne®) in symptomatic osteoarthritis of the hip: a prospective cohort study. Arch Orthop Trauma Surg 131, 1677–1685 (2011). https://doi.org/10.1007/s00402-011-1353-y
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DOI: https://doi.org/10.1007/s00402-011-1353-y