Phase 3
N=200
A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00398866 ↗Enrolled (actual)
200
Serious AEs
1.5%
Results posted
Jul 2017
Primary outcome: Primary: Pain Visual Analogue Scale (VAS) — 57.1; 63.2; 60.7; 42.9 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Synvisc (Hylan G-F20; hyaluronan injection) (Drug); Bupivicaine (local anesthesia injection) (Drug); Kenalog (triamcinolone; corticosteroid injection) (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Visual Analogue Scale (VAS) |
57.1; 63.2; 60.7; 42.9; 50.1; 49.8 | — |
| SECONDARY Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire |
25.7; 28.9; 28.8; 24.2; 27.0; 26.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT00398866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.