Treace Medical Concepts announced treatment of the first patient in the Mini3D™ Lapiplasty® clinical study. The study will evaluate outcomes using the Lapiplasty® Mini-Incision™ System.
The Prospective Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesis with Early Weight-Bearing after Lapiplasty ProceDure through a Mini-Incision Approach, or Mini3D, is a prospective, multicenter, unblinded post-market study designed to evaluate outcomes of the Lapiplasty Procedure using the Lapiplasty Mini-Incision System for patients in need of hallux valgus surgery. The study will evaluate for consistent and reliable correction of all three dimensions of the bunion deformity, as well as maintenance of such correction following accelerated return to weight-bearing, initially in a walking boot. The primary effectiveness endpoint is radiographic recurrence of the hallux valgus deformity at 24 months follow up. Key secondary endpoints include change in three-dimensional radiographic alignment; clinical radiographic healing; time to start of weight-bearing in a walking boot and in shoes; pain; quality of life; and range of motion of the big toe joint. The study will treat up to 200 patients in up to 20 centers.
Source: Treace Medical Concepts