LAPIPLASTY® 3D BUNION CORRECTION™ Clinical Study | Clinical Trial

Lapiplasty® 3D Bunion Correction™ Clinical Study

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.

Why is this study being done?

“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.”

The Align3D™ Lapiplasty® Clinical Study

  • Study Design: This study is a prospective, multicenter, unblinded study and will enroll up to 200 patients, aged 18 to 55 years, at up to 15 clinical sites in the United States.
  • Objectives: The post-market study is designed to evaluate the ability of the Lapiplasty® Procedure to consistently and reliably correct all three dimensions of the bunion deformity and maintain the correction following accelerated return to weight-bearing. The study’s primary endpoint is radiographic recurrence of the bunion 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.

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.

Important Risk Information: Only a surgeon can tell if the Lapiplasty® Procedure is right for you. As with any medical treatment, individual results may vary. There are potential risks and recovery takes time. Potential risks include but are not limited to infection, discomfort from the presence of the implant, loosening of the implant, and loss of correction with nonunion or malunion.