Clinical trial: Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis (NCT00918736)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Contradiction