A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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 with knee osteoarthritis, it is not yet FDA approved for use in the thumb. The purpose of this study is to determine the safety and effectiveness of hyaluronan in relieving arthritis symptoms at the base of the thumb and to compare it to corticosteroids and local anesthetic. The principle hypothesis is that treating osteoarthritis at the carpometacarpophalangeal (CMC) joint with injectable hyaluronan will results in greater pain relief, higher patient satisfaction, and better functional outcomes than treating with placebo injections (local anesthetic) or with corticosteroid injections. Treating CMC osteoarthritis with corticosteroid injections will result in greater pain relief, higher patient satisfaction, and better functional outcomes than treating with placebo injections. Patients with worse pre-treatment function will have less improvement and worse post-treatment results after administration of corticosteroid or hyaluronan.

Key facts

Study ID

NCT00398866

Run by

Hospital for Special Surgery, New York

People needed

200

Starts

2006-08-01

Expected to finish

2013-03-01

Last updated by the study team

2017-07-07

Who can join

Age: 45 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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