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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.

Contact
Treace Medical Concepts, Inc.
Robert Jordheim
Chief Financial Officer
rjordheim@treace.net
(904) 373-5940

Reference link: https://www.businesswire.com/news/home/20181112005775/en/Treace-Medical-Announces-Enrollment-Patient-ALIGN3D%E2%84%A2-Post-Market


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.

 

 

November 12, 2018

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 […]
November 7, 2018

New techniques employed at WVU Medicine make use of the latest technology to correct the long-time bane of the human foot: bunions.

Nov. 7, 2018 – Dr. Robert Santrock, chief of foot and ankle surgery at West Virginia University Medicine, was featured in an article and accompanying video on WVNews.com about Lapiplasty® 3D Bunion Correction™. Dr. Santrock noted that, until recently, surgical correction of a bunion involved either shaving off the bump or cutting and shifting the bones so it can look like the bump went away.  Neither approach addresses the root cause of bunions, which is an unstable joint toward the middle of a patient’s foot.   The Lapiplasty® Procedure involves realigning the bones back into their natural position in all three […]
November 1, 2018

Banish Bunions for Good

Nov. 1, 2018 – Ivanhoe Broadcast News, a news organization that provides a variety of stories to local television newscasts around the country, produced a segment on Lapiplasty® 3D Bunion Correction™. Dr. Adam Katz at Premier Podiatry Group in Boynton Beach FL, explained that traditional methods of surgical correction often have poor outcomes because they do not permanently stabilize the root cause of a patient’s bunion; an unstable joint.  This is a key function of the Lapiplasty® procedure and why it was designed.  Also included in the segment is Dr. Katz’ patient, Carrie, who expressed her happiness with the Lapiplasty® […]
October 4, 2018

New bunion surgery cuts recovery time

Oct. 4, 2018 – Dr. Christopher Pappas from the Holy Cross Orthopedic Institute in Fort Lauderdale and his patient Andrea spoke to the ABC affiliate in Miami/Ft. Lauderdale about Lapiplasty® 3D Bunion Correction™. Dr. Pappas explained how the Lapiplasty® Procedure allows him to realign and restore his patient’s normal foot anatomy and permanently secure the unstable joint which is the true case of a bunion deformity. As a result, patients are back on their feet far quicker than the 6-8 weeks needed for the traditional bunion correction surgery.  After undergoing the Lapiplasty® Procedure, Andrea was back on her feet in just […]
September 17, 2018

Study Of Triplane Bunion Correction System Shows Strong Results After One Year

September 2018 – Multicenter clinical data presented at the American Orthopaedic Foot and Ankle Society annual meeting demonstrated that Lapiplasty® 3D Bunion Correction™ is effective in correcting bunions in three planes. The average time for bearing weight following surgery was 10.5 days and at an average 13.5 month follow up, 96.7 percent of patients maintained three-plane correction. Study coauthor Paul Dayton, DPM, FACFAS notes the Lapiplasty® Procedure can help the surgeon correct the bunion deformity at the anatomic apex, resulting in more complete correction. He says the system provides simultaneous triplane correction and offers “very consistent and reproducible” results. Reference Link: […]
August 28, 2018

FOX affiliate in Columbia, S.C. aired two live segments during the morning news on bunions and Lapiplasty® 3D Bunion Correction™

Aug. 28, 2018 – Columbia, S.C. –  The FOX affiliate in Columbia, S.C. aired two live segments during the morning news on bunions and Lapiplasty® 3D Bunion Correction™. In the first segment, Dr. W Bret Smith discussed the anatomy of bunions and noted that the Lapiplasty® Procedure allows surgeons to fix bunions in three-dimensions, resulting in low recurrence rates. In the second segment, Dr. Smith is joined by his patient Sandy Smith (no relation), who chose the Lapiplasty® Procedure to correct bunions on both feet. Sandy explained that she was able to bear weight shortly after each procedure, which allowed her […]