Status:
COMPLETED
A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Genzyme, a Sanofi Company
Conditions:
Osteoarthritis
Eligibility:
All Genders
45-95 years
Phase:
PHASE3
Brief Summary
Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and that is often low in people with osteoarthritis. Although hyaluronan has been used in millions of people w...
Detailed Description
Osteoarthritis involves a wearing down of the cartilage within a joint. It can affect any joint in the body, but it most commonly affects joints in the hands, hips, knees, and spine. Over the last few...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00398866
Start Date
August 1 2006
End Date
March 1 2013
Last Update
July 7 2017
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021