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 Correction™procedure. 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.”
Mini3D™ 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 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.
ClinicalTrials.gov Identifier: NCT05082012
Lapiplasty® 3D Bunion Correction™ utilizing the Lapiplasty® Mini-Incision™ System is NOT an Investigational Device and has been cleared by the FDA.
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
Contact: William Duke, DPM
United States – Texas
Foot & Ankle Associates of North Texas – Keller
816 Keller Parkway Ste 101
Keller, TX 76248
Contact: Paul Steinke, DPM