Clinical trial: A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb (NCT00398866)

Eligibility criteria:
Inclusion Criteria:

          -  Presence of osteophytes or sclerosis at the carpometacarpal (CMC) joint

          -  Complaint of unacceptable pain despite modification of activity and a therapeutic dose
             of nonsteroidal anti-inflammatory drugs (NSAIDS), if tolerated

          -  If bilateral disease, only the most severely involved hand (as defined by the visual
             analog scale [VAS] for pain) will be entered in the study

          -  Able to follow instructions and complete questionnaires

          -  Failed conservative therapy with NSAIDS or COX-2 inhibitors

          -  Unable to tolerate COX-2 inhibitors

        Exclusion Criteria:

          -  Previous traumatic dislocation, ligament tear, or fracture of the thumb in the
             affected hand

          -  Previous hand surgery on the affected hand

          -  Known hand comorbidities (e.g., active carpal tunnel syndrome, de Quervains
             tenosynovitis, etc.)

          -  Systemic rheumatic disease

          -  Bleeding diatheses or anti-coagulation

          -  Allergies to steroids, chicken products, bupivicaine, or adhesive (e.g., double-sided
             tape)

          -  Current use of oral or intravenous steroids

          -  Active systemic malignancies

          -  Hyaluronan injection in the target CMC joint in the last 6 months

          -  Steroid or hyaluronan injection in any other joint in the last 6 months

          -  Insulin dependent diabetes mellitus (IDDM)

          -  Active infection

          -  Pain in the index joint that is more than 40 out of 100 on a VAS Pain scale

          -  End Stage CMC osteoarthritis, equivalent to bone on bone, Kellgren and Lawrence Stage
             IV

          -  Grade 3 or 4 Eaton and Litter (E+L) Classification

          -  E+L 3: Advanced joint distraction, subchondral cysts, and sclerosis

          -  E+L 4: Involvement of several joint surfaces
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 95 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? Entailment