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Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle.

Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle. Research Abstract Details 

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  • Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle. Abstract Text:

    BACKGROUND: The potential benefit of hyaluronans in alleviating pain associated with osteoarthritis (OA) in joints other than the knee is of increasing interest. This double-blind, randomized, controlled study examined the safety and efficacy of intraarticular sodium hyaluronate (Hyalgan) in the treatment of pain associated with ankle OA. MATERIALS AND METHODS: Thirty consecutive patients with ankle OA documented by X-ray were randomized to treatment with five weekly injections of either sodium hyaluronate 2 mL (HYL) or phosphate-buffered saline 2 mL (control) in the tibiotalar joint. The primary endpoint was pain on movement and weightbearing using the Ankle Osteoarthritis Scale (AOS) 3 months after injection (a 100-mm visual analog scale [VAS]). Additional measures included the Western Ontario and McMaster Universities (WOMAC) OA Index and patient global assessment through 6 months; the Short Form-12 (SF-12) Health Survey at 3 months and 6 months; and all reported adverse events (AEs). RESULTS: The study groups differed only in age, baseline WOMAC pain, and AOS total scores; 80% of the HYL and 73% of the control patients completed the study. At Month 3, the primary endpoint of the study, the HYL group demonstrated a significantly greater improvement from baseline in AOS total score than did the control group (HYL: -17.4 +/- 5.0 mm; Control: -5.1 +/- 4.0 mm; p = 0.0407). The incidence of AEs was low, with no significant differences between the groups. There were no post-injection flares. CONCLUSION: Our study suggests that sodium hyaluronate may be a safe and effective option for pain associated with ankle OA, although larger studies are needed.

    Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle. Publishing Authors By Initials

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    Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle. Journal Published:

    PUBLICATION TYPE: Research Support, Non-U.S. Gov

    Journal: Foot & ankle international / American Orthopaedic

    VOLUME: 29

    Page Numbers: 657-63

    Journal Abbreviation:

    ISSN: 1071-1007

    DAY: 12

    MONTH: Jul

    YEAR: 2008

    Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle. Information

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    LANGUAGE: eng

    NlmUniqueID: 9433869

    Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle. Keywords Mesh Terms:

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    Grant and Affiliation Information for Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle.

    AFFILIATION: Miami Veterans Affairs Medical Center, Surgical Service, 1201 NW 16th St, Miami, FL 33125, USA. michael.cohen@med.va.gov

    Country: United States

    United States Research PublicationUnited States Research Publication

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    MEDLINETA: Foot Ankle Int

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