Treace Medical Announces Enrollment of the First Patient in the ALIGN3D™ Post-Market Clinical Study of Lapiplasty® 3D Bunion Correction™
Multicenter prospective study aims to validate long-term maintenance of 3-dimensional correction following early return to weight-bearing
PONTE VEDRA, FLA. – November 12, 2018 – Treace Medical Concepts, Inc., a medical device company focused on advancing the standard of care for hallux valgus (bunion) surgery, today announced the initiation and first patient enrollment in the ALIGN3D™ post-market study to evaluate outcomes of Lapiplasty® 3D Bunion Correction™ in the surgical management of symptomatic hallux valgus.
“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 could be 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.”
The first patient enrolled into this post-market study was treated at Jefferson City Medical Group (Jefferson City, MO) where Dr. JP McAleer is the principal investigator. “We are pleased to be participating in the ALIGN3D™ study designed to further validate the clinical benefits of the Lapiplasty® Procedure. My partner, Dr. William Duke and I have treated over 150 patients with the Lapiplasty® Procedure and have experienced excellent clinical outcomes while enabling our patients to get back on their feet significantly faster. We’re excited to have the opportunity to build upon the existing positive data and better define the long-term outcomes with the Lapiplasty® Procedure.” says Dr. McAleer.
ALIGN3D™ is a prospective, multicenter, unblinded study and will enroll up to 200 patients, aged 18 to 55 years, at up to 15 clinical sites in the United States. 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 hallux valgus 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.
“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.”
About Treace Medical Concepts, Inc.
Based in Ponte Vedra, FL, Treace Medical Concepts, Inc. is a privately-held medical device company focused on advancing the standard of care for the surgical management of bunion deformities. The company’s patented Lapiplasty® 3D Bunion Correction™ procedure is designed to reproducibly correct all three planes of the bunion deformity and address the root cause of the bunion, while allowing patients to start ambulating on the operative foot within days of surgery. To learn more about Lapiplasty® 3D Bunion Correction™, or find a Lapiplasty® surgeon in your area, please visit: www.AlignMyToe.com or www.treace.com/patients.
Treace Medical Concepts, Inc.
Chief Financial Officer
1 Jeuken RM, et al. Foot Ankle Int. 2016. 37:687-95.
2 Pentikainen I, et al. Foot Ankle Int. 2014. 35:1262-7.
3 Iyer S, et al. Foot Ankle Int. 2015 36:756-63.
4 Santrock R. Early Weight-bearing Following Three-Plane 1st TMT Correction with the Lapiplasty® Procedure: 13.5-Month Multicenter Outcomes. 2018 AOFAS Annual Meeting, Boston, Mass.
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