Interim Study Results: Treace ALIGN3D Clinical Study

Treace Medical Concepts announced positive interim results from the ALIGN3D™ clinical study of surgical treatment of hallux valgus with the Lapiplasty® 3D Bunion Correction™ procedure.

Data on the 128 study participants included in the interim analysis demonstrated:

• Early return to weightbearing in a walking boot at an average of 8.3 days
• Significant improvements in radiographic measurements of 3-dimensional bunion correction (hallux valgus angle, intermetatarsal angle, and tibial sesamoid position)
• 1.4% recurrence rate observed (1 out of 72 patients) at 12 months post-surgery
• Significant improvements in patient-reported pain reduction and quality of life measurements at 6 months, which were maintained at 12 months post-procedure

John T. Treace, CEO of Treace, said, “The Lapiplasty® 3D Bunion Correction™ system was developed to provide surgeons the tools and surgical methods to reliably correct all 3 dimensions of the bunion deformity and address its root cause. ALIGN3D™ is a unique and comprehensive 5-year study, and we are pleased to report these positive interim results. We look forward to continuing to build our robust portfolio of clinical evidence, as we advance the standard of care for bunion surgery with our proprietary Lapiplasty® procedure.”