Treace Medical Concepts has enrolled the first patient for ALIGN3D post-market study focused on assessing outcomes of Lapiplasty 3D Bunion Correction in the surgical management of symptomatic hallux valgus.
Image: Hallux Valgus. Photo: Courtesy of Cyberprout/Wikipedia.
Treace Medical is focused on advancing the standard of care for the surgical management of bunion deformities. The company specializes in the design, manufacture, and marketing of device and/or biologic solutions for foot and ankle physicians.
The company’s patented Lapiplasty 3D Bunion Correction procedure is designed to reproducibly correct all three planes of the bunion deformity and address the root cause of the bunion
It will enable patients to start ambulating on the operative foot within days of surgery.
The multicenter, unblinded ALIGN3D study will enroll up to 200 patients, aged between 18 and 55 years, at up to 15 clinical sites in the US.
It will assess the ability of the Lapiplasty Procedure to consistently and reliably correct all three dimensions of the bunion deformity and maintain the correction after accelerated return to weight-bearing.
The primary endpoint of the study is radiographic recurrence of the hallux valgus deformity at 24 months follow up.
Secondary endpoints include change in three-dimensional radiographic alignment, clinical radiographic healing, time to start of weight-bearing in a boot and in shoes, pain, quality of life, and range of motion of the big toe joint, Treace Medical said.
The first patient enrolled into this post-market study was treated at Jefferson City Medical Group where JP McAleer is the principal investigator.
Treace Medical CEO John Treace said: “With thousands of surgical cases performed, the Lapiplasty Procedure is being adopted rapidly across the United States as surgeons recognize the benefits of performing a 3-dimensional correction that also addresses the root cause of the bunion problem.
“We are excited to have initiated this important study, which we believe will further differentiate the Lapiplasty Procedure as the standard of care for bunion sufferers.”
Instead of cutting and shifting the bone over as traditional 2D surgery does, Lapiplasty uses advanced instrumentation to precisely reposition the entire misaligned bone back into normal 3D alignment.