A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb
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|ClinicalTrials.gov Identifier: NCT00398866|
Recruitment Status : Completed
First Posted : November 14, 2006
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Drug: Synvisc (Hylan G-F20; hyaluronan injection) Drug: Bupivicaine (local anesthesia injection) Drug: Kenalog (triamcinolone; corticosteroid injection)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Study of Hyaluronan (Synvisc) for the Treatment of Osteoarthritis in the Thumb: Randomized Control Trial|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Active Comparator: 1
Bupivicaine (local anesthetic)
Drug: Bupivicaine (local anesthesia injection)
1 ml of bupivicaine 0.5% injected once a week for 2 weeks
Active Comparator: 2
Corticosteroid (trimcinolone (Kenalog) 40 mg)
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
Drug: Synvisc (Hylan G-F20; hyaluronan injection)
1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
Other Name: Synvisc, Hyalgan, Hyaluronic Acid
- Pain Visual Analogue Scale (VAS) [ Time Frame: Baseline, 26 Weeks ]Pain intensity measured on a Visual Analog Scale with scores ranging from 0 to 100, with 100 = severe pain.
- Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire [ Time Frame: Baseline, 26 Weeks ]Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire measures degree of disability on a scale of 0 to 100, with a higher score indicating greater disability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398866
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Lisa A. Mandl, MD, MPH||Hospital for Special Surgery, New York|