Mixed Reviews for Knee Surgery Drug
After inconclusive trial, observers still see promise for post-arthroscopy remedy.
Published: December 31, 2012
A recently concluded clinical trial of a drug aimed at arthroscopic knee surgery patients demonstrated its effectiveness in handling post-op pain, but didn't show its ability to improve joint function, the manufacturer reported last week.
The drug, currently known as OMS103HP and manufactured by Seattle-based biopharmaceutical firm Omeros, is designed to be added to irrigation fluid and pumped into the joint during arthroscopic surgery. According to the company, it has been formulated to reduce post-op pain, swelling, clicking, catching and stiffness in the knee.
The multi-center trial observed 344 patients undergoing arthroscopic partial meniscectomies. Researchers found that the patients who were given OMS103HP intraoperatively needed fewer post-op pain medications, showed less inflammation and were less dependent on crutches than the control group. But they didn't see a difference between the drug and conventional treatments in reducing swelling, stiffness and other joint function factors.
The trial's observers still see promise for the drug, and the company is planning a second phase 3 trial for early 2013.
"The data from this Phase 3 trial are compelling and demonstrate the benefits of preemptive and multimodal treatment during surgery," says William E. Garrett, Jr., MD, PhD, a Duke University orthopedic surgeon. "Early postoperative pain is predominantly inflammatory pain, and control of postoperative pain and inflammation is critical to functional recovery in arthroscopy patients."
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