Clinical trial: The Efficacy of Viscosupplementation for Early Knee Osteoarthritis (NCT01210742)

Eligibility criteria:
Inclusion Criteria:

          -  18-70 years

          -  Radiographic evidence of OA in the tibiofemoral compartment (minute or definite
             osteophytes and a measurable joint space)

          -  Pain on walking (Visual Analogue Scale 0-10). Minimum of 4 and maximum of 9.

          -  Oxford knee score (OKS) of above 12 but below 36 (0-48, 48 no problem)

          -  Pain score of 1, 2 or 3 on Q1 (pain) of OKS.

          -  Suitable for viscosupplementation

        Exclusion Criteria:

          -  OKS of below 12 and above 36 (0-48, 48 no problem)

          -  Pain score of 0 or 4 on Q1 (pain) of OKS.

          -  Grade 3 or 4 patellofemoral degeneration (Kellgren-Lawrence classification).

          -  Grade 3 or 4 tibiofemoral degeneration (Kellgren-Lawrence classification).

          -  A clinically apparent tense effusion of the target knee.

          -  Significant valgus/varus deformities.

          -  Ligamentous laxity or meniscal instability.

          -  Viscosupplementation history in any joint in the past 9 months.

          -  Previous surgery at the target knee in the past 6 months.

          -  Concomitant inflammatory disease (rheumatoid arthritis) or other condition that
             affects the joints.

          -  Use of prohibited medication/treatment for chronic pain.

          -  Pregnancy or new mothers who are breastfeeding.

          -  Systemic or intra-articular injection of corticosteroids in any joint within 3 months
             prior to screening.

          -  Obvious cartilage defects producing mechanical symptoms (i.e. locking).

          -  Listed for a knee replacement procedure for osteoarthritis of the knee.

          -  Have a history of failed conservative treatment (exercise therapy, physiotherapy).
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 70 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