Cartiva, Inc. has enrolled its first patient in a study of the company’s ProxiFuse Hammertoe Compression System. ProxiFuse was designed for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
John Maskill, M.D., of Orthopaedic Associates of Michigan at the Metro Health/OAM Surgery Center in Grand Rapids, Michigan, treated the patient.
Hammertoes, according to Cartiva officials, are permanent and often painful deformities of the second, third or fourth toe that cause the toe to bend at the middle joint instead of pointing forward. Surgical correction of hammer toe deformities is said to be one of the most commonly performed forefoot procedures. The joint is straightened and fused, a procedure in which the ends of the bone are cut and aligned. Pins, screws or other implants keep the toe straight while the bone ends heal together. The ProxiFuse device is designed to provide optimal fixation, compression and stability following the procedure.
“Despite the number of new hammertoe implants that have been introduced in recent years, there is limited clinical evidence supporting their use, ” said Cartiva President and CEO Timothy J. Patrick. “The initiation of this observational study represents our commitment to provide foot and ankle surgeons and their patients with meaningful clinical data to make informed treatment decisions.”
Cartiva’s multicenter observational study is planned to enroll a minimum of 70 patients at six sites throughout the United States. Study assessments will be performed at baseline and at two weeks, six weeks, three months and six months following the surgical procedure.
