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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.”

3D LAPIPLASTY® CLINICAL STUDY

  • Study Design: This study is a prospective, multicenter, unblinded study and will enroll up to 200 patients, aged 14 to 58 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

Where are the clinical study sites?

United States – Lead Investigator Site
UT Southwestern Medical Center
1801 Inwood Rd #1
Dallas, TX 75235
214-645-8300

Contact: Dane Wukich, MD (primary investigator)
Dane.Wukich@UTSouthwestern.edu

Trapper Lalli, MD
George T. Liu, DPM
Katherine Raspovic, DPM
Michael VanPelt, DPM

United States – Colorado

Foot & Ankle Ctr of Northern Colorado
1931 65th Ave. Suite A
Greeley, CO 80634
970-351-0900

Contact: Daniel Hatch, DPM
dhatch@footandanklecolorado.com

United States – Iowa

Foot & Ankle Center of Iowa
3720 N. Ankeny Blvd. Suite 103
Ankeny, IA 50023
515-639-3775

Contact: Paul Dayton, DPM
daytonp@me.com

Mindi Dayton, DPM

United States – Missouri

JCMG Jefferson City Medical Group
1241 W. Stadium Blvd.
Jefferson City, MO 65019
573-556-7724

Contact: Jody McAleer, DPM
jmcaleer@jcmg.org

William Duke, DPM

United States – Nevada

Desert Orthopaedic Center
2800 E Desert Inn Rd,
Las Vegas, NV 89121
(702) 766-6514
Contact: Abdi Raissi, MD
teamraissi@doclv.com

United States – Pennsylvania

University of Pennsylvania
Perelman School of Medicine
3737 Market St, 6th Floor
Philadelphia, PA 19104
215-294-9650

Contact: Daniel Farber, MD
Daniel.Farber@pennmedicine.upenn.edu

United States – Texas

Stonebriar Foot & Ankle
5575 Warren Parkway, Suite 101
Frisco, TX 75034
972-712-4161

Contact: Robert Taylor, DPM
bobbyerl@msn.com

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As a medical device manufacturer, Treace Medical Concepts, Inc. cannot provide any opinions or other medical advice to patients. For medical advice please contact your doctor.