Business Wire07.05.19
Treace Medical Concepts Inc., 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 was published in Foot & Ankle International. The goal of the study, which involved multiple centers and 57 patients (62 feet), was to evaluate maintenance of three-plane correction and union rates following an early weight-bearing protocol. Highlights of the study:
“We are pleased to see our multicenter dataset published,” stated W. Bret Smith, D.O., 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 recurrence,1 as demonstrated in this study, has been a game-changer in my practice.”
Robert Santrock, M.D., associate professor and chair of foot and ankle surgery at West Virginia University, presented the results of the study dataset last year. According to Dr. Santrock, “Traditional osteotomy surgery has been associated with an unacceptably high rate of recurrence with studies citing a greater than 50 percent chance of the bunion returning over time.2 In this multicenter study, just two 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 four to eight 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.
Based in Ponte Vedra, Fla., 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 get back to their active lives quickly.
References
1 Ray JJ et al., Foot Ankle Int. 2019 [epub ahead of print]
2 Jeuken RM, et al. Foot Ankle Int. 2016; 37:687-95.
3 Data on file.
- Sixty-two feet met the one-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
- Nearly 97 percent (96.8) of study patients maintained their three-plane bunion correction as assessed by Intermetatarsal Angle (IMA), Hallux Valgus Angle (HVA) and Tibial Sesamoid Position (TSP) at the one-year plus endpoint
- Symptomatic non-union rate of 1.6 percent (one foot)
“We are pleased to see our multicenter dataset published,” stated W. Bret Smith, D.O., 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 recurrence,1 as demonstrated in this study, has been a game-changer in my practice.”
Robert Santrock, M.D., associate professor and chair of foot and ankle surgery at West Virginia University, presented the results of the study dataset last year. According to Dr. Santrock, “Traditional osteotomy surgery has been associated with an unacceptably high rate of recurrence with studies citing a greater than 50 percent chance of the bunion returning over time.2 In this multicenter study, just two 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 four to eight 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.
Based in Ponte Vedra, Fla., 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 get back to their active lives quickly.
References
1 Ray JJ et al., Foot Ankle Int. 2019 [epub ahead of print]
2 Jeuken RM, et al. Foot Ankle Int. 2016; 37:687-95.
3 Data on file.