ALIGN3D™ Lapiplasty® Clinical Study
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.”
ALIGN3D™ 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
Contact: Dane Wukich, MD (primary investigator)
Trapper Lalli, MD
George T. Liu, DPM
Katherine Raspovic, DPM
Michael VanPelt, DPM