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

NCT ID: NCT00398866

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2013-03-31

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 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.

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 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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Bupivicaine (local anesthetic)

Group Type: ACTIVE_COMPARATOR

Bupivicaine (local anesthesia injection)

Intervention Type: DRUG

1 ml of bupivicaine 0.5% injected once a week for 2 weeks

2

Corticosteroid (trimcinolone (Kenalog) 40 mg)

Group Type: ACTIVE_COMPARATOR

Kenalog (triamcinolone; corticosteroid injection)

Intervention Type: DRUG

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

3

Synvisc

Group Type: EXPERIMENTAL

Synvisc (Hylan G-F20; hyaluronan injection)

Intervention Type: DRUG

1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks

Interventions

Synvisc (Hylan G-F20; hyaluronan injection)

1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks

Intervention Type: DRUG

Bupivicaine (local anesthesia injection)

1 ml of bupivicaine 0.5% injected once a week for 2 weeks

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Synvisc, Hyalgan, Hyaluronic Acid

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa A. Mandl, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

K23AR050607

Identifier Type: NIH

Identifier Source: secondary_id

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5K23AR050607-04

Identifier Type: NIH

Identifier Source: secondary_id

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26043

Identifier Type: OTHER

Identifier Source: secondary_id

K23AR050607

Identifier Type: NIH

Identifier Source: org_study_id

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