Cartiva, a developer of orthopedic implants, has completed enrolling patients in its MOTION trial.
The prospective, multi-center trial, which has enrolled 233 patients across Canada and the UK, is designed to assess the company's Cartiva synthetic cartilage implant (SCI) and compare it with arthrodesis, the current standard of care, for reducing pain associated with osteoarthritis of the metatarsophalangeal joint in the great toe.
Composite evaluation of three study outcomes including pain, function and safety are the primary endpoint of the study.
MOTION trial investigator and Queen Elizabeth Sciences Center othopaedics surgery assistant professor Mark Glazebrook said 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.
"Additionally, in a fusion procedure, the remaining cartilage and adjacent bone are removed in order to fuse the two bones that form the joint," Glazebrook added.
"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.
