Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: sodium hyaluronate
Intervention description: 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ankle joint; Balance; Hyaluronic acid; Osteoarthritis

Summary:

      The aim of this study was to investigate the efficacy and safety of three weekly
      intraarticular injections of Hyaluronate (HA) in patients with unilateral ankle
      Osteoarthritis (OA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  were 18 years of age or older, reported unilateral ankle pain for at least 6 months
             and had either reported no significant benefit from conservative treatment (rest,
             physical therapy, orthoses or pain medications etc.) or were unable to tolerate side
             effects of medications

          -  ankle radiographs taken within 6 months were equivalent to grade 2 or 3 according to
             the Kellgren-Lawrence grading system (grade 2, definite osteophytes and possible
             narrowing of joint space; grade 3, moderate multiple osteophytes, definite narrowing
             of joint space, some sclerosis and possible deformity of bone contour)22

          -  had a current total AOS score (described below) of > 3 and < 9 (possible range, 0-10)

          -  were normally active, not bedridden or confined to a wheelchair, and were able to walk
             30 meters without the aid of a walker, crutches or cane

          -  were willing to discontinue all nonsteroidal anti-inflammatory drugs (NSAIDs) or other
             analgesic medication (except for rescue medication) for the duration of the study

          -  did not receive physical therapy or trial of shoe modifications or orthotics during
             the study period

        Exclusion Criteria:

          -  pregnant and lactating women

          -  bilateral ankle OA requiring treatment of both ankles

          -  chronic ankle instability

          -  lower leg trauma other than within the ankle

          -  previous orthopedic surgery on the spine, hip or knee

          -  presence of active joint infections of foot or ankle

          -  previous surgery or arthroscopy on the ankle within 12 months

          -  intraarticular steroid or HA injection in the treated ankle within the past 6 months

          -  treatment with anticoagulants or immunosuppressives

          -  history of rheumatoid arthritis, gout, or any other inflammatory arthropathy

          -  history of avian protein allergy

          -  presence of other comorbidity (neoplasm, diabetes mellitus, paresis, recent trauma,
             etc) or poor health status that would interfere with the clinical assessments during
             the study