A Study of Hyaluronan (Synvisc) for the Treatment of Osteoarthritis in the Thumb: Randomized Control Trial

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.

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
Jeffrey N. Katz, MD, MS
Jason Guardado (Office Manager)
Nadia Baranchuk (Study Coordinator)  
Julian Lagoy (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     
Jonathan Weisz (Research Assistant)  

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.  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
  5mm we will defer to patients preference.
• Able to follow instructions and complete questionnaires.
• Failed conservative therapy with non-steroidal anti-inflammatories/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. active carpal tunnel syndrome, de Quervains Tenosynovitis etc)
• Systemic rheumatic disease
• Bleeding diatheses or anti-coagulation, 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

Contact Information

Clinical Research Coordinator
212.774.2960