A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Synvisc (Hylan G-F20; hyaluronan injection); Bupivicaine (local anesthesia injection); Kenalog (triamcinolone; corticosteroid injection)
Intervention description: 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
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Bupivacaine; Hyaluronic Acid; Hylan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 45 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Hyaluronan; Carpometacarpal; Outcomes; Carpometacarpal Joints

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.
    

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