New York City—February 1, 2010
The study is recruiting adults with osteoarthritis of the thumb, a wear-and-tear disease different from rheumatoid arthritis. Degeneration of the cartilage in the thumb is a common problem in older adults that can significantly affect their quality of life, according to Dr. Lisa Mandl, a rheumatologist at Hospital for Special Surgery and lead investigator of the trial.
Dr. Mandl is studying whether two injections of hyaluronan (brand name: Synvisc) into the joint, in the area where the thumb meets the wrist, can alleviate pain and restore function. Synvisc is currently FDA-approved to treat osteoarthritis of the knee.
In 2004, Dr. Mandl and colleagues at HSS conducted an open-label trial of Synvisc to relieve thumb arthritis pain in 32 patients, and the data looked promising. “In the first study, we saw a significant decrease in pain,” she said. “That’s why we decided to go forward with a much larger double-blind, placebo-controlled trial and applied for funding from the NIH and the Arthritis Foundation. Genzyme Biosurgery is supplying the medication free of charge.”
Dr. Mandl is seeking to enroll 213 patients who will be randomly assigned in equal numbers to one of three groups. The first group will receive hyaluronan, a second group will receive a cortisone shot and the third group will receive a local anesthetic. Patients will be followed for six months to see how they fare.
Osteoarthritis of the thumb can cause severe pain and is more common in women than men. A full 30 percent of women age 65 to 74 are estimated to have arthritis in their thumb, and 80 percent of women will have it once they turn 80.
“Often, this type of arthritis is the only problem in very active, healthy people. It’s the one thing that’s really interfering with their life,” Dr. Mandl notes. “They wake up at night, they can’t work, they can’t pick up a pen. It disproportionately ruins their life. If we had a good treatment that didn’t have side effects, their lives would improve dramatically.”
Other treatments, such as non-steroidal anti-inflammatory medications, can have side effects or don’t work for many patients. “Cortisone shots are a common treatment, but not everyone is a candidate, and these injections are not great for maintenance therapy.” Dr. Mandl said.
“We’ve had patients with terrible pain who are desperate. One woman started to cry when she learned she did not qualify for the study,” Dr. Mandl said. When conservative treatments fail to provide relief, the next step is surgery.
Adults over 45 with painful thumb arthritis may be candidates for the trial. They will be screened by a study questionnaire, hand x-ray and hand exam. All medication will be provided free of charge. “An advantage for all study participants is that at the end of six months, everyone is eligible to receive Synvisc free of charge, provided they complete the study,” Dr. Mandl says.
Anyone who would like more information about the study is invited to call the clinical research coordinator at 212-774-2960.
About Hospital for Special Surgery
Founded in 1863, Hospital for Special Surgery (HSS) is a world leader in orthopedics, rheumatology and rehabilitation. HSS is nationally ranked No. 2 in orthopedics, No. 3 in rheumatology and No. 24 in neurology by U.S.News & World Report (2009), and has received Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center, and has one of the lowest infection rates in the country. In 2008 and 2007, HSS was a recipient of the HealthGrades Joint Replacement Excellence Award. A member of the NewYork-Presbyterian Healthcare System and an affiliate of Weill Cornell Medical College, HSS provides orthopedic and rheumatologic patient care at NewYork-Presbyterian Hospital at New York Weill Cornell Medical Center. All Hospital for Special Surgery medical staff are on the faculty of Weill Cornell Medical College. The hospital's research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. Hospital for Special Surgery is located in New York City and online at www.hss.edu.