Treace Medical Announces Publication of Additional Positive Clinical Data Supporting Lapiplasty® 3D Bunion Correction™
108 patient study published in The Journal of Foot & Ankle Surgery demonstrates 99.1% maintenance of correction in bunion patients treated with Lapiplasty® surgery
Treace Medical Concepts, Inc., a medical device company focused on advancing the standard of care for hallux valgus (bunion) surgery, announces publication of new positive clinical data supporting Lapiplasty® 3D Bunion Correction™ in The Journal of Foot & Ankle Surgery.1 The objective of the study was to compare radiographic measurements of 3-plane bunion correction in patients before and after receiving triplane first tarsometatarsal arthrodesis procedure and to assess radiographic recurrence and healing rates. Highlights of the study:
- 108 patients (109 feet) were included in the study with average follow up of 17.4 months
- Patients were allowed to begin weight-bearing on their operative foot in a surgical boot within the first week of surgery
- All patients achieved successful bone healing of the operative joint with 99.1% of patients maintaining their 3-plane correction (0.9% recurrence rate)
- No cases of hardware failure were reported
When asked for comment, Paul Dayton, DPM of the Midwest Bunion Center / Foot and Ankle Center of Iowa (Ankeny, IA) and lead author on the publication stated, “This study demonstrates the ability of the triplane first tarsometatarsal arthrodesis correction procedure to provide a robust and reliable correction of all 3 planes of the bunion deformity with a very low rate of recurrence and low rate of healing problems at a mean of 17 months postoperatively.1 Given conventional 2-dimensional metatarsal osteotomy surgery shows radiographic recurrence rates as high as 30 – 78% in the scientific literature,2,3 these results are quite promising. With the knowledge of the power of triplane correction, the doctors at Midwest Bunion Center have been utilizing the Lapiplasty® 3D correction system since 2015 to provide the most consistent results for our patients”, Dr. Dayton concluded.
“The outcomes of this new study are noteworthy in that they reinforce the results reported in our 13-month multicenter dataset published in Foot & Ankle International (FAI),” said Robert Santrock, MD of West Virginia University and co-author on the FAI paper. “In the FAI publication, the 62 feet treated with Lapiplasty® 3D Bunion Correction™ showed a low 1.6% symptomatic non-healing rate and 3.2% radiographic recurrence rate following early weight-bearing in a post-operative boot at an average of 10.9 days”.4
“The combination of rapid return to weight-bearing and low radiographic recurrence rates, now demonstrated across multiple studies, is highly encouraging for bunion sufferers”, says John T. Treace, CEO of Treace Medical. “This study represents the 13th peer review publication supporting the Lapiplasty® procedure, another important milestone for our company that is recognized as the industry leader in advancing the scientific study of hallux valgus. Over 15,000 Lapiplasty® procedures have now been performed in the US, and with a pipeline of additional studies underway, we continue to build upon the robust clinical dossier supporting the Lapiplasty® procedure so that patients, practitioners, and payors can make treatment decisions based on clinical evidence.”
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.
- Dayton P, et al., J Foot Ankle Surg [epub ahead of print]
- Bock P, et al., J Bone Joint Surg Am. 2015; 97:1238-45.
- Jeuken RM, et al., Foot Ankle Int. 2016; 37:687-95.
- Ray JJ, et al., Foot Ankle Int. 2019; 40:955-960.