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).
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.
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.
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.
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