MTA3D Adductoplasty Clinical Study

Why is this study being done?

“Recurrence rates following traditional hallux valgus correction are found to be significantly higher when certain deformities of the midfoot are present.1,2 With the Adductoplasty® and Lapiplasty® instrumentations, we now have technologies to enable reproducible correction of both the bunion and coexisting midfoot deformities,” said Paul D. Dayton, DPM, MS, FACFAS of Foot & Ankle Center of Iowa and co-lead principal investigator, along with Mark Easley, MD of Duke University. “With the first patient now treated, we look forward to advancing the MTA3D™ Clinical Study and reporting on outcomes following the procedure.”

John T. Treace, CEO, Founder and Board Member of Treace said, “We see significant opportunity to advance not only the standard of care in the surgical management of bunions with our flagship Lapiplasty®system, but also in the surgical treatment of concomitant midfoot deformities, which can occur in up to 30% of bunion patients, with our Adductoplasty®system. The MTA3D™ Clinical Study builds upon our leadership position in delivering differentiating multicenter, prospective clinical studies to support these novel therapy platforms.”

MTA3D™ Adductoplasty®Clinical Study

• Study Design: This study is a prospective, multicenter, unblinded study and will treat up to 80 patients, aged 14 to 60 years, at up to 10 clinical sites in the United States.
• Objectives: The post-market study is designed to evaluate outcomes of the Adductoplasty® Procedure combined with the Lapiplasty® Procedure for patients in need of hallux valgus and metatarsus adductus surgery. To evaluate the quality of life and pain scores following the Adductoplasty® Procedure in combination with the Lapiplasty® Procedure. And, to determine whether the Adductoplasty® Procedure, in combination with the Lapiplasty® Procedure, effectively corrects and maintains triplane anatomical alignment of the 1st, 2nd and 3rd metatarsals, the hallux position, the sesamoid position, and the foot width. The study’s primary endpoint is sustained radiographic correction of the hallux valgus deformity with metatarsus adductus at 24 months follow up. Secondary endpoints include clinical radiographic healing; any clinical complications through the duration of the 60 month follow up; time to start weight-bearing in a boot and in shoes; change in pain; quality of life; range of motion of the big toe joint; as well as change in radiographic foot width.

ClinicalTrials.gov Identifier: NCT05082012

The Adductoplasty® Procedure in combination with the Lapiplasty® Procedure utilizing: Lapiplasty® Lesser TMT Fixation, Adductoplasty® Reusable Instruments, Lapiplasty® System Implants, and/or Lapiplasty®Reusable Instruments are NOT Investigational Devices.

Where is the clinical study site?