Cartiva Starts Postmarket Study of its ProxiFuse Hammertoe System

Cartiva Inc., a developer technology to treat cartilage damage, osteoarthritis and other musculoskeletal conditions, has enrolled the first patient in a prospective, observational study of its U.S. Food and Drug Administration-cleared ProxiFuse hammertoe compression system.

The multicenter postmarket study is designed to demonstrate the safety and effectiveness of ProxiFuse for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

According to the company, the first study patient was successfully treated by John Maskill, M.D., of Orthopaedic Associates of Michigan at the Metro Health/OAM Surgery Center in Grand Rapids, Mich.

Hammertoes 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 hammertoe deformities is one of the most commonly performed forefoot procedures. One routine procedure is straightening and fusing the joint, in which the ends of the bone are cut and aligned. Pins, screws or other implants are used to 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 Timothy J. Patrick, president and CEO of Cartiva. “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.”

The study is a prospective, multicenter observational study that will 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 after the surgical procedure. Outcomes will be collected and measured using the validated National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS). The primary endpoint for the study will evaluate the six-month post-surgery change from baseline in the PROMIS Pain Interference computerized adaptive test (CAT) score. Secondary endpoints will include change from baseline in PROMIS Pain Interference CAT and PROMIS Physical Functioning CAT at two weeks, six weeks and three months after surgery, time to return to normal shoe wear and postoperative adverse events that require a return to the operating room.

Alpharetta, Ga.-based Cartiva is venture backed, with firms including New Enterprise Associates, Windham Venture Partners and Domain Associates.