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 HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the eighth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2017-2018). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.