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Mini3D Lapiplasty® Clinical Study

Why is this study being done?

“The Lapiplasty® Mini-Incision system and approach have been adapted to enable the same 3-dimensional correction that address the root cause of the bunion problem typically through a smaller 3.5cm incision vs. the standard Lapiplasty® system.  When compared with traditional MIS osteotomies, the Lapiplasty® Mini-Incision enables the proper realignment of the first metatarsal bone, restoring natural anatomy, without the need to cut and shift bone to improve appearance,” said Dr. Jody McAleer, DPM, FACFAS Jefferson City Medical Group Department of Podiatry, MO and lead principal investigator.  “With the first patient now treated, we look forward to advancing the study and reporting on long term outcomes following the procedure.”

John T. Treace, CEO of Treace commented, “We are committed to driving clinical data evaluating our Lapiplasty® 3D Bunion Correctionprocedure.  The Mini3D study builds on our ongoing ALIGN3D study, but through a Mini-Incision approach, providing both patients and physicians with another option to correct bunion deformity.  Study participants will be followed for 24 months after the surgical procedure.”


  • 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 20 clinical sites in the United States.
  • Objectives: The post-market study is designed to evaluate the ability of the Lapiplasty® Mini-Incision 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 changes in three-dimensional radiographic alignment; clinical radiographic healing; time to start of weight-bearing in a boot and in shoes; pain; quality of life; range of motion of the big toe joint; change, if any, in the initial incision length and scar quality; change in radiographic foot length and width as well as swelling; and any correlation between the amount of time an external positioner is actively used during the procedure with necrosis, blistering, bruising, and tissue ulceration. Identifier: NCT05082012

Lapiplasty® 3D Bunion Correction utilizing the Lapiplasty® Mini-Incision System is NOT an Investigational Device.

Where are the clinical study sites?

United States – Lead Investigator Site
JCMG Jefferson City Medical Group
1241 W. Stadium Blvd.
Jefferson City, MO 65019

Contact: Jody McAleer, DPM

William Duke, DPM

United States – Alabama

DOC – Decatur Orthopaedic Clinic
1103 16th Ave SE
Decatur, AL 35601
(256) 350-0362

Contact:  Justin Daigre, MD

United States – Alabama

DOC – Decatur Orthopaedic Clinic
615 Mynatt St. SW Suite B
Hartselle, AL 35640
(256) 350-0362

Contact:  Justin Daigre, MD

United States – Arizona

Phoenix Foot and Ankle Institute
7301 E 2nd Street, Ste 206
Scottsdale, AZ 85251
(602) 761-7819

Contact: Jeffrey E. McAlister, DPM

United States – Florida

Orlando Foot and Ankle Clinic
Waterford Lakes Office
250 N. Alafaya Trail | Suite 115
Orlando, FL  32825
(407) 447-1020

Contact:  Kaitlyn Hammock, DPM

Contact:  Amber Shane, DPM

United States – Pennsylvania

University of Pennsylvania / Penn Medicine
Farm Journal Building
230 W. Washington Square
Philadelphia, PA 19106
(215) 662-3340

Contact:  Ellen Stinger, MS

Contact:  Daniel Farber, MD

United States – Nevada

Desert Orthopaedic Center
2800 East Desert Inn Rd | Suite 100
Las Vegas, NV 89121
(701) 731-1616

Contact:  Abdi Raissi, MD

United States – Texas

Stonebriar Foot and Ankle
5575 Warren Pkwy Suite 101
Frisco, TX 75034
(972) 712-4161

Contact: Robert Taylor, DPM

United States – Texas

Foot & Ankle Associates of North Texas – Keller
816 Keller Parkway Ste 101
Keller, TX 76248
(817) 416-6155

Contact:  Paul Steinke, DPM

United States – Texas

Sports Medicine Associates of San Antonio
21 Spurs Lane Ste 300
San Antonio, TX 78240
(210) 699-8326

Contact:  Marque Allen, DPM

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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.