Clinical trial: Synvisc-One for Younger, Active Patients With Osteoarthritis (NCT01625013)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female patients aged 30-50 years

          -  History of symptomatic unilateral primary or secondary knee OA for more than 6 months

          -  Signed written informed consent

          -  Radiographic evidence of Kellgren-Lawrence Grade I or II OA of the target knee

          -  Body Mass Index (BMI) < 30 kg/m2

          -  Activity criteria (Tegner score > 3)

          -  Continued target knee OA pain despite conservative treatment ≥ 3 months (e.g., weight
             reduction, physical therapy, analgesics)

          -  Willing to withhold intake of NSAIDs (including COX-2 inhibitors) and analgesics, for
             a washout period of minimum 3 days up to 21 days prior to baseline visit (depending on
             medication)

          -  Willing to discontinue prohibited treatments and medications throughout study period

        Baseline inclusion criteria

          -  Completed OA medication washout period

          -  Target knee pain 4-8 (0-10 NRS) during most painful knee movement (Worst Knee Pain)

          -  If female, must have had a negative urine pregnancy test and used a medically
             acceptable form of contraception for at least 1 month prior to baseline and agree to
             continued use of contraception for the duration of the study. Otherwise, females must
             be surgically sterile, or postmenopausal (as documented in medical history) for at
             least 1 year. The fetal safety profile for G-F 20 is unknown. Pregnancy will affect
             the individual's regular activity levels. Females who become pregnant during the study
             will be excluded from the study. Subjects who become pregnant will be followed up by
             telephone every 3 months to check for any adverse effects. They will also be
             recommended to follow routine obstetric visits. Males should be able to father
             children as it has no expected effects on activity levels.

        Exclusion Criteria:

          -  Known allergy to hylan G-F 20 or any of its components, or to avian proteins, eggs,
             feathers, down, or poultry

          -  Clinically apparent tense effusion or other acute inflammation of the target knee at
             baseline

          -  History of target knee viscosupplementation treatment

          -  History of major surgery for OA in target knee including arthroplasty or tibial
             osteotomy

          -  Arthroscopic surgery or intraarticular steroid injection in target knee within six
             months of baseline visit

          -  Significant (as judged by the Investigator) alignment deformity of target knee

          -  Ipsilateral symptomatic OA of hip or ankle; contralateral symptomatic OA of hip, knee,
             or ankle

        History of:

          -  Septic OA of any joint

          -  Inflammatory arthropathy such as RA, gout, pseudogout, lupus, crystalline inflammatory
             arthropathy

          -  Active infection of lower extremity

          -  Known significant acute and/or concurrent medical disease including, but not limited
             to current malignancy, history of transplant surgery, congestive heart failure,
             significant unstable cardiovascular disease, renal hepatic pulmonary, endocrine,
             metabolic, or GI condition

          -  Any known contraindication to acetaminophen

          -  Venous or lymphatic stasis in either leg

          -  Peripheral vascular disease

          -  Patient has been prescribed chronic opioid analgesics at time of baseline visit

          -  Concurrent multi-system or multi-limb trauma

          -  Patient plans to become pregnant during study period

          -  Patient plans to move significantly out of area, have surgery, or initiate or cease
             other OA treatments

          -  Knee pain improves during washout period

          -  Workman's Comp patient
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Contradiction