October 16, 2007
A Study of Hyaluronan (Synvisc) for the Treatment of Osteoarthritis in the Thumb: Randomized Control Trial
IRB Number: 26043
Institutional Review Board
Hospital for Special Surgery
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Principal Investigator
Lisa A. Mandl, MD, MPH
Co-Investigators
Robert N. Hotchkiss, MD
Ronald S. Adler, MD, PhD
Stephen A. Paget, MD
Francisco Valero-Cuevas, PhD
Scott W. Wolfe, MD
Edward A. Athanasian, MD
Aaron Daluiski, MD
Michelle G. Carlson, MD
Sherry Backus, MAPT
Madhusudhan Venkadesan
Stephen Lyman, PhD
Summary
213 subjects will be recruited and randomly assigned one of three interventions:
- Hyaluronan (Synvisc) injections
- Corticosteroid injections
- Local Anesthetic injections
The study lasts for 26 weeks, and includes 5 visits to HSS (including 2 injection visits) and 2 mailings.
Subjects will be screened for eligibility by a study questionnaire, hand x-ray and hand exam.
Inclusion/Exclusion Criteria
Inclusion Criteria:
• The presence of osteophytes, sclerosis or joint narrowing at the CMC joint
• Patient complaint of unacceptable pain despite modification of activity, and a therapeutic dose of NSAIDS, if tolerated
• Over 45 years old.
• If bilateral disease, only the most severely involved hand, will be entered in the study.
• Able to follow instructions and complete questionnaires.
• Failed conservative therapy with non-steroidal anti-inflammatories / COX-2 inhibitors.
• Unable to tolerate COX-2 inhibitors.
Exclusion criteria:
• Pregnancy
• Prisoners
• Previous traumatic dislocation, ligament tear or fracture of the thumb in the injected hand
• Previous thumb surgery on the affected hand
• Known hand comorbidities (i.e. carpal tunnel syndrome, de Quervains Tenosynovitis etc)
• Systemic rheumatic disease
• Bleeding diatheses or anti-coagulation
• Allergies to steroids, chicken products, bupivicaine, or adhesive (i.e. double-sided tape)
• Current use of oral or intravenous steroids
• Active systemic malignancies
• Steroid or HA injection in the target CMC joint in the last 6 months
• HA injection in any other joint in the last 6 months
• Insulin dependent diabetes mellitus (IDDM)
• Active infection
• Pain in the index joint <40/100 on a VAS Pain scale
Contact Information
Clinical Research Coordinator
212.774.2960
