Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatments synvisc (hylan g-f20; hyaluronan injection), bupivicaine (local anesthesia injection), kenalog (triamcinolone; corticosteroid injection)
Phase phase 3
Sponsor Hospital for Special Surgery, New York
Collaborator National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date August 2006
End date March 2013
Trial size 213 participants
Trial identifier NCT00398866, 26043, 5K23AR050607-04, K23 AR050607, K23AR050607

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Bupivicaine (local anesthetic)
bupivicaine (local anesthesia injection)
1 ml of bupivicaine 0.5% injected once a week for 2 weeks
(Active Comparator)
Corticosteroid (trimcinolone (Kenalog) 40 mg)
kenalog (triamcinolone; corticosteroid injection)
1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation
(Experimental)
Synvisc
synvisc (hylan g-f20; hyaluronan injection) Synvisc, Hyalgan, Hyaluronic Acid
1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks

Primary Outcomes

Measure
Disabilities of the arm, shoulder, and hand outcome measure
time frame: Measured during the 6-month duration of participation

Secondary Outcomes

Measure
Visual analog scale for pain
time frame: Measured during the 6-month duration of participation

Eligibility Criteria

Male or female participants from 45 years up to 95 years old.

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

Additional Information

Official title A Study of Hyaluronan (Synvisc) for the Treatment of Osteoarthritis in the Thumb: Randomized Control Trial
Principal investigator Lisa A. Mandl, MD, MPH
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 years, a new medicine called hyaluronan has been used for treating osteoarthritis. 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. Specifically, the study will evaluate pain relief, patient satisfaction, and functional outcomes among participants. Participation in this study will last 26 weeks. Screening will include a questionnaire and an x-ray of the affected thumb. Eligible participants will then be randomly assigned to one of three treatments: two hyaluronan injections, one corticosteroid injection plus one local anesthetic injection, or two local anesthetic injections. Participants will receive the injections at the base of their thumb, and the first injection will be followed by the second injection a week later. There will be five study visits that will occur at baseline and Weeks 2, 4, 12, and 26. All study visits will include questionnaires, and except for the Week 2 study visit, they will also include an examination and evaluation of the affected thumb. Photographs of the thumb will be taken at baseline. The injections will occur at baseline and Week 2. At Weeks 8 and 20, questionnaires will be mailed to participants for them to complete. Upon completing the study, participants will have the option of receiving continued treatment with another round of hyaluronic injections.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Hospital for Special Surgery, New York.