Orthopedic implants developer Cartiva has completed enrolling patients in its MOTION trial, designed to evaluate the Cartiva synthetic cartilage implant (SCI) as a treatment for reducing pain associated with osteoarthritis of the metatarsophalangeal joint.
The prospective, multi-centre trial has enrolled 233 patients across Canada and the UK to demonstrate the safety and effectiveness of the Cartiva SCI and it compared with arthrodesis, the current standard of care.
Composite evaluation of three study outcomes including pain, function and safety are the primary endpoints of the study.
MOTION trial investigator and Queen Elizabeth Sciences Centre othopaedics surgery assistant professor Mark Glazebrook said that although pain is often eliminated, a fusion does not allow patients to maintain motion in the joint and requires approximately six weeks to recover in a cast.
"In a fusion procedure, the remaining cartilage and adjacent bone are removed in order to fuse the two bones that form the joint," he said.
"Cartiva SCI has been designed to offer a minimally invasive alternative that preserves more bone and allows patients to maintain motion and return to normal activity much sooner."
The company will use the trial results to submit Cartiva SCI's premarket approval application to the US Food and Drug Administration.
Cartiva president and CEO Timothy Patrick said that Cartiva SCI had been approved for use in Canada, Europe and Brazil for more than ten years, and has been implanted in thousands of patients to address the pain and functional limitations associated with osteoarthritis.
"Based on the outcomes of the trial, we also hope to provide patients in the United States with an advanced, less-invasive technology to help reduce pain and increase mobility," he said.