HSS Investigating Sustained-Release Implant for Severe Knee OA
Hospital for Special Surgery (HSS) in New York and pSivida Corp. have opened an investigational new drug application (IND) to begin an investigator-sponsored clinical study of a sustained-release implant to treat severe osteoarthritis (OA) of the knee.
The implant is designed to provide long-term pain relief for severe knee OA, which is anticipated to delay the need for knee replacement surgery.
The implant (Figure 1) is surgically implanted into the non-articulating area of the knee in an outpatient procedure. Although the study is designed to evaluate the implant for 6 months, the duration of release following a single treatment is expected to extend to 1 year or more.
Figure 1. Sustained-release implant.
Mark P. Figgie, MD, Chief of the Surgical Arthritis Service at HSS, filed the IND and will serve as the principal investigator for the investigator-sponsored study.
Dr. Figgie is a leading expert in joint replacement for inflammatory arthritis and performs more than 500 joint replacement surgeries each year. With training in engineering and biomechanics, he has been instrumental in the design of implants for elbows, knees, and hips.
The study will be an open-label, single dose, safety, and tolerability study of the screw implant to deliver dexamethasone. Six patients will receive the implant in one knee. Although it is a safety and tolerability study, change from baseline in weekly mean of pain intensity scored at rest, during activity and at night, will be assessed weekly through 24 weeks.
Knee OA affects more than 10 million individuals, and the degeneration, damage, and pain it causes can be severe enough to warrant total knee arthroplasty (TKA).
More than 700,000 TKAs were performed last year in the U.S. alone, and the number is expected to grow. Recent data from the Centers for Disease Control indicate that TKA doubled between 2000 and 2010 for Americans over age 45, due in part to longer life expectancies and increases in obesity.
“We believe this product has the potential to provide long-term pain relief and to contribute to improved joint function for patients with severe osteoarthritis, which can delay knee replacement surgery,” said Dr. Robert Hotchkiss, Medical Director of Clinical Research, HSS.
“Implanting a small, secure reservoir that delivers a corticosteroid on a sustained basis directly to the knee could avoid the issues with systemic steroid delivery and repetitive knee injections. This implant, the result of the combined insights HSS and the expertise of pSivida, has the potential to create a paradigm shift in a variety of conditions.”