Objectives To evaluate the effectiveness of a single intra-articular injection of hylan G-F 20 (Synvisc) for symptomatic first metatarsophalangeal joint (MTPJ) osteoarthritis (OA).
Methods Participants (n = 151) with symptomatic first MTPJ OA were randomly allocated to receive up to 1 ml intra-articular injection of either hylan G-F 20 or placebo (saline). Participants and assessors were blinded. Outcomes were evaluated at 1, 3 and 6 months after injection. The primary outcome measurement was the foot pain domain of the Foot Health Status Questionnaire (FHSQ) at 3 months. Secondary outcome measurements were foot function assessed via the FHSQ, first MTPJ pain and stiffness, magnitude of symptom change, global satisfaction, health-related quality of life (assessed using the Short-Form-36 version two), first MTPJ dorsiflexion range of motion, hallux plantar flexion strength, use of pain-relieving medication or co-interventions and changes in plantar pressures.
Results No statistically significant differences in foot pain were found between the groups at 3 months. There were few statistically significant differences in the secondary outcome measures. Overall, the incidence of adverse effects was not significantly different between groups.
Conclusions An intra-articular injection of hylan G-F 20 is no more effective than a placebo in reducing symptoms in people with symptomatic first MTPJ OA.Australian New Zealand Clinical Trials Registry: number ACTRN12607000654459.
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Funding This study was funded by the Australian Podiatry Education and Research Foundation (APERF) and the La Trobe University Faculty of Health Sciences. Genzyme Australasia Pty. Ltd. (North Ryde, NSW, Australia) provided the hylan G-F 20 (Synvisc) product and partially funded the costs associated with advertising, radiographs, assessment of serum uric acid of participants and fluoroscopic injections. HBM is currently a National Health and Medical Research Council fellow (Clinical Career Development Award, ID: 433049).
Competing interests None.
Ethics approval This study was conducted with the approval of the La Trobe University Human Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.