SBU Orthopaedic Research Team Wins National Award
SBU ORTHOPAEDIC RESEARCH TEAM WINS NATIONAL AWARD FOR A NEW TREATMENT OF DEBILITATING HAND DISORDER, FROZEN SHOULDER
Drs. Hurst, Badalamente and Wang Receive Award at Annual AAOS Meeting
STONY BROOK, N.Y., March 24, 2009 - A team of Othopaedic faculty researchers at Stony Brook University Medical Center
are the recipients of the 2009 American Academy of Orthopaedic Surgeons (AAOS) Clinical Research Award, a prestigious award sponsored by the Orthopaedic Research and Education Foundation (OREF) and Kappa Delta Sorority. Lawrence C. Hurst, M.D., Marie A. Badalamente, Ph.D., and Edward D. Wang, M.D., received the award at the AAOS Annual Meeting in Las Vegas in February for their work over the last 10 years on the use of collagenase in the treatment of two fibroproliferative disorders - Dupuytren's disease, a hand disorder characterized by progressive accumulation of collagen that deforms the fingers of the hand and limits motion, and frozen shoulder.
The Stony Brook researchers have shown in clinical trials that the use of an enzyme, a collagenase preparation called clostridial collagenase, may be an effective injectable, non-surgical alternative to treat Dupuytren's disease (also called Dupytren's contracture) and frozen shoulder (adhesive capsulitis). The team discovered that injecting clostridial collagenase greatly improved the deformities caused by the collagen build-up, called cords, in the hands of patients with Dupuytren's contracture and appeared to loosen the collagenous adhesions present in the capsule of patients with frozen shoulder.
The work on the clostridial collagenase has progressed in Dupuytren's contracture, and the team has entered into clinical trials of an injectible drug that they developed to treat patients in the United States and Australia. New drug approval was submitted to the FDA on March 2 for the Dupuytren's disease indication.
"Though the standard of care for Dupuytren's disease is surgery, injection therapy such as clostridial collagenase is showing promising results for patients with this disease," says Dr. Hurst, Co-Principal Investigator, Professor and Chair of the Department of Orthopaedics. "We have found that injections of our formulation into the cords which cause finger contractures from the disease weakens the cord. In most patients the finger can be manipulated the next day and the cord ruptured, which results in correction of the contracture without surgery."
Dr. Hurst and co-investigators emphasize in their report on the research, titled "Injectable Clostridial Collagenase: Striving Toward Non-Operative Treatment Options For Fibroproliferative Disorders," that surgery is far from an ideal form of treatment for many patients with Dupuytren's disease. They indicate that most patients with Dupuytren's disease are elderly or have other significant comorbidities (i.e. diabetes) and therefore are often not ideal candidates for an invasive procedure. In addition, neurovascular injury, hematoma, and infection can occur during or following surgery, and in patients with severe contractures digital nerve damage is a risk. Recurrence after surgery also remains problematic, as 30 percent of patients on average experience a recurrence within two years after surgery.
The authors point out that the need for new treatments for fibroproliferative disorders is paramount because quality of life is seriously impacted for those who suffer from the conditions. Their report also details the results of clinical studies of clostridial collagenase for Dupuytren's disease and frozen shoulder. They tested various doses of clostridial collagenase to determine effectiveness of the treatments. A dose of 10,000 units (0.58 mg) was determined to be the minimum safe and effective dose. When injecting this dose for Dupuytren's disease, Dr. Hurst and colleagues reduced contractures in metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints within zero degrees to five degrees of normal extension (zero degrees) within 30 days post-injection.
"Encouragingly, clinical efficacy appears to be durable," wrote the authors, "with long-term follow-up of patients indicating that recurrence rates are low (approximately 10 percent for MP joints and 20 percent for PIP joints at five-year follow-up)."
In a pilot study of clostridial collagenase injections to treat frozen shoulder, the authors concluded "this investigational minimally invasive injection therapy shows potential for patients with fibroproliferative disorders affecting the musculoskeletal system." However, the authors call for further studies to confirm their observations and suitability of the treatment for frozen shoulder.
The Stony Brook researchers received a plaque and a cash prize of $20,000 for the Clinical Research Award. The award is given by the OREF to encourage clinical research in orthopaedics. Since 1950, the OREF and Kappa Delta has given nearly $1.1 million in support of orthopaedic research through these awards.
The OREF is the only independent surgeon-driven organization supporting research in the musculoskeletal area. Founded in 1933, the AAOS is the preeminent provider of musculoskeletal education to orthopaedic surgeons worldwide.
The Department of Orthopaedics at Stony Brook University Medical Center provides full-service patient care and sub-specialty resident and faculty training in all areas of orthopaedics. The department includes a comprehensive Orthopaedic Research Program featuring clinical and laboratory facilities and resources for investigation of molecular, biologic, and biomechanical research topics.