A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Synvisc (Hylan G-F20; hyaluronan injection); Bupivicaine (local anesthesia injection); Kenalog (triamcinolone; corticosteroid injection)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks; 1 ml of bupivicaine 0.5% injected once a week for 2 weeks; 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
Other intervention name(s): Synvisc, Hyalgan, Hyaluronic Acid
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Bupivacaine; Hyaluronic Acid; Hylan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hyaluronan; Carpometacarpal; Outcomes; Carpometacarpal Joints