Institutional Review Board, Hospital for Special Surgery
October 16, 2007
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.
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, DPT
Stephen Lyman, PhD
Jeffrey N. Katz, MD, MS
Stuart Davidson (Study Coordinator)
Eric Bogner, MD
Avni Patel, PharmD
Gregory R. Saboeiro, MD
Madhu Mazumdar, PhD
Karen H. Costenbader, MD, MPH
Lana Kang, MD
Quynh Tran, RN
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.
NOT RECRUITING NEW SUBJECTS
• 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. Population based data suggest that basilar thumb OA which occurs at younger ages may be due to other etiologies (i.e. trauma).
Although response to treatment in these two groups may be similar, we wish to keep our disease sample as homogenous as possible; therefore in this
study we are excluding younger patients.
• If bilateral disease, only the most severely involved hand, (as defined by VAS for pain), will be entered in the study. If VAS scores differ by less than 3mm we will defer to patients preference.
• Able to follow instructions and complete questionnaires.
• Failed conservative therapy with non-steroidal anti-inflammatories/COX-2 inhibitors.
• 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. active carpal tunnel syndrome, de Quervains, Tenosynovitis etc.)
• Systemic rheumatic disease
• Bleeding diatheses or anti-coagulants, anti-platelet agents are permitted.
• Allergies to steroids, chicken products, hyaluronan, or bupivicaine.
• 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, and steroid injection in any other joint in the last month. Patients may receive an HA injection in another joint apart from this study one month after study injections if they so elect.
• Insulin dependent diabetes mellitus (IDDM)
• Active infection
• Pain in the index joint <35/100 on a VAS Pain scale
Clinical Research Coordinator