Clinical trial: Efficacy and Safety of Intraarticular Injections of Hyalgan in the Treatment of Osteoarthritis of the Knee (NCT01319461)

Eligibility criteria:
Inclusion Criteria:

          -  1.Male or female patients whose specific ages are > 50 years old, in general health.
             2.Must be ambulatory (assistive devices allowed) 3.Patient was diagnosed as OA of knee
             joint by American College of Rheumatology (ACR) criteria ; [ ie,knee pain, and any one
             of the following:age>50 years,crepitus, or morning stiffness<30 minutes in duration ]
             4.Radiographic confirmation of OA with Kellgren-Lawrence Ⅱ-Ⅲ score (mild to
             moderate)at the target joint (anterior-posterior views) with predominance in the
             tibia-femoral compartment 5.VAS score ≧40 mm for 50 foot of walking pain.

        Exclusion Criteria:

          -  1.Patients with severe degeneration of knee joint with marked joint narrowing, marked
             varus or valgus deformity of the knee greater than 12 o. 2.Patients with hepatic or
             renal failure, or other chronic severe diseases that can interfere with the outcome.
             3.A known history of psychiatric diseases, significant neurological diseases, allergy
             or sensitivity to hyaluronic acid or avian protein. 4.Patients receive steroid
             intraarticular injection, anti-inflammatory agents less than two weeks. 5.Patients
             with joint disorders: inflammatory joint disease, specific arthropathy
             (chondrocalcinosis, joint effusion >30ml), severe axis deviations or instabilities,
             joint or skin infections, joint prostheses of the lower limbs, symptomatic hip.
             6.Significant alcohol, drug or medication abuse as judged by the investigator.
             7.Pregnancy determined by clinical evaluation or urine testing for nursing women
             and/or women of childbearing potential not using a medically approved means of
             contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or
             Norplant). 8.Patients who have taken any other "investigational" drug within one month
             prior to the screening visit.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 80 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? 1