This page contains information about clinical studies that are sponsored by Treace Medical Concepts, Inc. If you wish to learn more about any of Treace Medical’s sponsored clinical studies, and/or find doctors who are actively engaged in Treace’s clinical trials, please visit ClinicalTrials.gov by clicking the corresponding identifier number listed below.
IMPORTANT NOTE – The clinical trial associated with the Lapiplasty® Procedure is a post-market clinical study, which means that Lapiplasty® 3D Bunion Correction™ has already received FDA Clearance and is not an investigational procedure. Having already performed thousands of procedures, Treace Medical has initiated a post-market clinical study to validate the long-term outcomes related to the treatment of Hallux Valgus (Bunions) with the Lapiplasty® Procedure.
“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,” said John T. Treace, CEO of Treace Medical. “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.”
“High radiographic recurrence rates for surgical procedures that don’t address all 3 dimensions of the hallux valgus deformity have been well-documented. Studies critically evaluating metatarsal osteotomy surgeries demonstrate recurrence rates as high as 50-78 percent for these procedures,”1,2,3 said Dane Wukich, M.D., Professor and Chairman, Department of Orthopaedic Surgery at the UT Southwestern Medical Center and the study’s lead principal investigator. “Previously presented clinical data on the Lapiplasty® Procedure with early return to weight-bearing demonstrated a 3.3 percent recurrence rate at 13.5 months.4 The ALIGN3D™ study will determine recurrence at 24 months and produce a robust dataset that will provide additional insight into the Lapiplasty® Procedure across a number of endpoints.”
ClinicalTrials.gov Identifier: NCT03740282
Lapiplasty® 3D Bunion Correction™ is NOT An Investigational Device and has been cleared by the FDA. Click here for more information
1 Jeuken RM, et al. Foot Ankle Int. 2016. 37:687-95.
2 Pentikainen I, et al. Foot Ankle Int. 2014. 35:1262-7.
3 Iyer S, et al. Foot Ankle Int. 2015 36:756-63.
4 Santrock R. Early Weight-bearing Following Three-Plane 1st TMT Correction with the Lapiplasty® Procedure: 13.5-Month Multicenter Outcomes. 2018 AOFAS Annual Meeting, Boston, Mass.