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Product / Company Performance

Treace Medical Kicks Off Postmarket Study of Bunion Correction -

Treace Medical Concepts enrolled the first patient in the ALIGN3D™ U.S. postmarket study of Lapiplasty® 3D Bunion Correction™, addressing all three planes of deformity. The two-year prospective, multicenter, unblinded study will enroll up to 200 patients at up to 15 sites, evaluating the procedure's ability to consistently correct all three dimensions of the bunion deformity and maintain correction following accelerated return to weight-bearing. The primary endpoint is radiographic recurrence of the hallux valgus deformity at two-year 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. (Treace Medical Concepts, Inc., 11/13/18)