Treace Medical Concepts, a medical device company focused on advancing the standard of care for hallux valgus (bunion) surgery, announces publication of positive results from its retrospective, multicenter study with the Lapiplasty 3D Bunion Correction procedure for the surgical management of symptomatic hallux valgus.
The clinical paper titled “Multicenter Early Radiographic Outcomes of Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing”1 recently published in Foot & Ankle International, the official journal of the American Orthopaedic Foot & Ankle Society. The goal of the study, which involved multiple centers and 57 patients (62 feet), was to evaluate maintenance of 3-plane correction and union rates following an early weight-bearing protocol. Highlights of the study:
62 feet met the 1-year endpoint, with an average follow-up of 13.5 months
Mean time for study patients to start weight-bearing in a boot walker on their operative foot was 10.9 days
96.8% of study patients maintained their 3-plane bunion correction as assessed by Intermetatarsal Angle (IMA), Hallux Valgus Angle (HVA) and Tibial Sesamoid Position (TSP) at the 1 year+ endpoint
Symptomatic non-union rate of 1.6% (1 foot)
“We are pleased to see our multicenter dataset publish in Foot & Ankle International,” states W. Bret Smith, DO, Clinical Assistant Professor of Orthopaedic Surgery at University of South Carolina, author and enrolling center in the study. “These early results are quite encouraging and offer a viable new option for patients seeking surgical management of this painful and activity limiting deformity. Offering a therapy that allows my patients the benefits of both early weight-bearing in a boot walker and low recurrence1, as demonstrated in this study, has been a game-changer in my practice.”
Robert Santrock, MD, Associate Professor and Chair of Foot and Ankle Surgery at West Virginia University, presented the results of the study dataset at last year’s AOFAS annual meeting in Boston. According to Dr. Santrock, “Traditional osteotomy surgery has been associated with an unacceptably high rate of recurrence with studies citing a greater than 50% chance of the bunion returning over time.2 In this multicenter study, just 2 of 62 feet treated with the Lapiplasty 3D procedure demonstrated 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 boot walker, 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.
“This multicenter study represents the 10th peer review publication supporting the Lapiplasty Procedure, an important milestone for our company which was recently recognized as the industry leader in contributing most to the scientific study of the bunion deformity by an independent survey of 3,000 foot and ankle surgeons.3 With additional studies underway, we continue to build upon the clinical dossier supporting the Lapiplasty Procedure so that patients, practitioners, and payors can make treatment decisions based on clinical evidence,” stated John T. Treace, Treace Medical’s CEO and Founder.
Source: Company Press Release.