Volume 4 Supplement 1

Proceedings of the Australasian Podiatry Council Conference 2011

Open Access

Intra-articular hyaluronan (Synvisc®, hylan G-F 20) for the treatment of first metatarsophalangeal joint osteoarthritis: a randomised, placebo controlled trial

  • Gerard V Zammit1Email author,
  • Shannon E Munteanu1, 2,
  • Hylton B Menz1,
  • Karl B Landorf1, 2,
  • Christopher J Handley1, 3,
  • Ayman ElZarka4 and
  • Jason DeLuca4
Journal of Foot and Ankle Research20114(Suppl 1):O54

DOI: 10.1186/1757-1146-4-S1-O54

Published: 20 May 2011

Background

The objective of this randomised controlled trial (RCT) was to comparatively assess the effectiveness of intra-articular hyaluronan (Synvisc®, hylan G-F 20) against an intra-articular sterile saline placebo for the treatment of radiographically confirmed, symptomatic first metatarsophalangeal joint (MTPJ) osteoarthritis (OA).

Methods

One hundred and fifty one (n=151) participants with symptomatic first MTPJ OA were randomly allocated to receive up to 1ml intra-articular injection of either Synvisc®, hylan G-F 20 or a sterile saline placebo. Outcomes were evaluated at 1, 3 and 6 months post-injection. Primary outcome measurements included the foot pain and foot function sub-scales of the Foot Health Status Questionnaire (FHSQ). Secondary outcome measurements were pain at the first MTPJ during walking and rest, self-reported stiffness at the first MTPJ, magnitude of symptom change with allocated treatment, global satisfaction, health-related quality of life (assessed via the Short-Form-36, version two), first MTPJ dorsiflexion range of motion, strength of the hallux plantarflexors, use of pain-relieving medication, concomitant therapies and dynamic plantar pressures.

Results

This RCT was completed in July 2010, with 147 (97%) participants followed up at 1 month, 127 (84%) at 3 months and 135 (89%) at 6 months. Both the placebo and treatment groups displayed improvements at the 1, 3, and 6 month follow-up periods. However, there were no statistically significant differences between the placebo or treatment groups for the primary outcome measures of FHSQ foot pain and foot function during any review period. With few exceptions, there were no statistically significant differences in the secondary outcome measurements between the groups.

Conclusions

A single intra-articular injection of Synvisc®, hylan G-F 20 is no more effective than a single intra-articular injection of sterile saline (placebo) in reducing symptoms and improving function in people with symptomatic, radiographically confirmed first MTPJ OA.

Authors’ Affiliations

(1)
Musculoskeletal Research Centre, Faculty of Health Sciences, La Trobe University
(2)
Department of Podiatry, Faculty of Health Sciences, La Trobe University
(3)
School of Human Biosciences, Faculty of Health Sciences, La Trobe University
(4)
Southern Cross Medical Imaging, La Trobe University Private Hospital

Copyright

© Zammit et al; licensee BioMed Central Ltd. 2011

This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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