Clinical trial: Effectiveness and Safety of Synvisc® Versus Usual Treatments in Patients With Knee Osteoarthritis (NCT02197026)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female outpatient aged at least 18 years

          -  Patient suffering from predominant femoro-tibial knee osteoarthrosis with or without
             effusion. The diagnosis must be based on American College of Rheumatology (ACR)
             criteria. Radiological grade will be assess according to Kellgren-Lawrence scale

          -  Assessment of pain on active movement (i.e. walking) (by the patient) must be at least
             40 mm on a 100 mm VAS

          -  Patient who received at least two courses of at least ten days within the last three
             months with non-steroidal antiinflammatory drugs (NSAID) and/or who are treated
             continuously for the last two month with slow-acting anti-osteoarthritis drugs

          -  Patient's informed written consent obtained in accordance with French legislation

        Exclusion Criteria:

          -  Patient suffering from acute congestive osteoarthritis flare of the target knee (at
             the time of inclusion) which means that concomitantly to knee effusion at least 2 of
             the following criteria are present:

               -  nocturnal disturbances due to knee pain

               -  morning stiffness over 45 minutes

               -  increase of knee pain more than 50% within the last week

               -  articular reddening

               -  articular heat

          -  Intra-articular administration of hyaluronic acid in the target knee within the
             previous year

          -  Intra-articular administration of hyaluronic acid in the target knee within the three
             previous months

          -  Any other intra-articular injection in the target knee within the last 6 months

          -  Any contraindication to intra-articular injections

          -  Present or past history of infected target knee joint

          -  Previous prosthesis knee surgery, tibial osteotomy, synovectomy or synoviorthese of
             the target knee

          -  Arthroscopy, articular lavage, debridement, menisectomy of the target knee within the
             previous year

          -  Planned knee surgery within the nine following month

          -  Any other musculoskeletal disorders that can interfere with osteoarthritis diagnosis
             or the evaluation of its severity

          -  Known hypersensitivity to avian products

          -  Presence of lymphatic or venous stasis

          -  Pregnancy or breastfeeding

          -  Clinical evidence of or known severe cardiac, hepatic, renal, metabolic,
             haematological disease, mental disturbance

          -  Participation in another clinical trial during this study or during the previous month

          -  Previous participation in this trial

          -  Patient who requires help concerning shopping or house keeping

          -  Patient unable to comply with the protocol (e.g. patient unable to attend each trial
             visit or to fill the diary booklet or the quality of life questionnaire)
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.


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? Entailment