PONTE VEDRA, Fla.--(BUSINESS WIRE)--Treace Medical Concepts, Inc., a medical device company focused on advancing the standard of care for hallux valgus (bunion) surgery, announces presentation of positive 13.5-month follow-up results from its retrospective, multicenter study with the Lapiplasty® 3D Bunion Correction™ procedure in the surgical management of symptomatic hallux valgus. The goal of the study, which involved multiple centers and 72 patients, was to evaluate maintenance of 3-plane correction and union rates with rapid return to weight-bearing following surgery. Highlights of the study:
- 61 feet met the 1-year endpoint, with an average follow-up of 13.5 months
- Mean time for study patients to start weight-bearing on the operative foot was 10.5 days
- 96.7% of study patients maintained their 3-plane correction: Intermetarsal Angle (IMA), Hallux Valgus Angle (HVA) and Tibial Sesamoid Position (TSP)
- Symptomatic non-union rate of 1.6% (1 foot)
Robert Santrock, MD, Associate Professor and Chair of Foot and Ankle Surgery at West Virginia University, presented the results on July 12th at the annual meeting of the American Orthopaedic Foot & Ankle Society (AOFAS) in Boston, MA. According to Dr. Santrock, “Traditional osteotomy surgery has been associated with an unacceptably high rate of recurrence on x-ray with studies citing a greater than 50% chance of the bunion returning over time. In our study, only 2 feet (or 3.3%) treated with the Lapiplasty® 3D procedure experienced a radiographic recurrence of their bunion at 13.5 months. This low rate of recurrence represents what we believe to be a very significant finding. Importantly, our patients were able to start bearing weight within days of surgery in a post-operative boot, versus 4-8 weeks in casts as with some traditional surgical approaches.”
The patented Lapiplasty® 3D Bunion Correction™ procedure represents a new paradigm in the assessment and surgical management of hallux valgus, a deformity of the foot which affects about 60 million Americans and results in approximately 400,000 surgeries in the United States annually.
Paul Dayton, DPM, of the Midwest Bunion Center, a study enrolling site, comments: “Traditional bunion surgery only addresses 1 (or 2) of the 3 planes involved in the complex bunion deformity. Studies demonstrate a significant increase in the likelihood of the bunion returning if all 3 planes are not properly realigned in the surgical procedure. The Lapiplasty® 3D Bunion Correction™ procedure offers novel instrumentation and implants designed to reproducibly realign all 3 planes of the deformity and, as importantly, stabilize an unstable joint in the middle of the foot which is the root cause of the bunion. This allows patients to start ambulating quickly and, as seen in our study, with a very low chance of recurrence.”
“This is exciting news for bunion sufferers. The low recurrence rate demonstrated in this 13.5-month, multicenter study is highly encouraging, particularly given how quickly these patients started ambulating on their operative foot. With the Lapiplasty® 3D Bunion Correction™ procedure, patients have a new alternative to the inconsistent results of traditional osteotomy surgery, one designed to deliver a comprehensive and lasting correction to this complex deformity," says John T. Treace, Treace Medical’s CEO and Founder.
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 3 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.