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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Collaborators: Genzyme, a Sanofi Company; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Bupivacaine; Hyaluronic Acid; Hylan; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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