Treace Announces Peer-Reviewed Publication of Multicenter Prospective Clinical Data of ALIGN3D™
PONTE VEDRA, Fla., May 05, 2022 (GLOBE NEWSWIRE) — Treace Medical Concepts, Inc. (“Treace”) (Nasdaq: TMCI), a medical technology company pioneering fundamental change in the surgical treatment of hallux valgus (commonly known as bunions) through its Lapiplasty® 3D Bunion Correction™ procedure, today announced the publication of a peer-reviewed manuscript that details an interim dataset from its prospective clinical study multicenter ALIGN3D™ in the Journal of foot and ankle surgery.
Publication of the intermediate results of “One- and Two-Year Analysis of a Five-Year Prospective Multicenter Study Assessing Radiographic and Patient-Reported Data Results after a first triplanar tarso-metatarsal arthrodesis with early weight bearing for symptomatic hallux valgus” include data on 117 patients with at least 12 months and 40 patients with at least 24 months of follow-up (out of a total of 173 study patients) following the Lapiplasty® procedure, showed:
Early recovery of support in a walking boot at 7.8 days on average;
Significant improvement in radiographic measures of three-dimensional bunion correction from pre-surgery to 6 weeks and maintained at 12 months (n=108) and 24 months (n=38) post-operatively, with 1 recurrence reported at 12 months postoperative (recurrence rate of 0.9%); and
Return to work within 4 weeks (25.2 days) and to full and unrestricted activity within 4 months post-operative on average.
Additionally, the study reported a statistically significant improvement in patient-reported outcomes (PRO) on three validated scoring systems, including the Visual Analogue Pain Score (VAS), the Manchester-Oxford Foot Questionnaire ( MOxFQ) and patient-reported outcome measurement information systems. (PROMIS-29). At 24 months after surgery (n=40), patients reported over 80% reduction in pain from preoperative levels according to VAS and MOxFQ scoring systems, while an 87% improvement was observed in walking/standing as well as social interaction using the MOxFQ scoring system. Additionally, statistically significant improvement in physical, mental, and social health scores was reported using the PROMIS-29 scoring system.
John T. Treace, CEO, Founder and Member of the Board of Directors of Treace, said, “We are delighted to announce our first peer-reviewed ALIGN3D™ publication in the Journal of foot and ankle surgery report the results of the study over one and two years. This type of multi-center prospective study is unique in the field of bunion surgery, and these positive interim data document the positive outcomes of patients using our proprietary Lapiplasty® procedure. In line with our corporate mission to improve surgical outcomes for patients with bunions, we continue to build on our unique and differentiated set of clinical data and advance the Lapiplasty® procedure as the standard of care for the bunion surgery.
The publication, which includes additional details such as patient demographics, inclusion/exclusion criteria, and complications reported in the study, is available on the website Journal of foot and ankle surgery website and is also available on Treace Medical website.
On the ALIGN3D™ Clinical Study
The ALIGN3D™ clinical study is a prospective, multicenter, post-marketing study designed to evaluate the results of Lapiplasty® 3D Bunion Correction™ in the surgical management of symptomatic hallux valgus. The study will assess the consistent and reliable three-dimensional correction of bunion deformity with the Lapiplasty® procedure, as well as the maintenance of such correction after an accelerated return to weight bearing, initially in a walking boot. The primary efficacy endpoint is radiographic recurrence of the hallux valgus deformity at 24 months of follow-up. Key secondary endpoints include change in three-dimensional radiographic alignment; clinical radiographic healing; time of onset of support in boots and shoes; pain; quality of life; and range of motion of the big toe joint. The study recruited 173 patients, ages 14 to 58, at 7 clinical sites in the United States with 13 participating surgeons. Final patient follow-up for the primary endpoint is expected in the first half of 2023.
On Trace Medical Notions
Treace Medical Concepts, Inc. is a medical technology company focused on advancing the standard of care for the surgical management of bunion deformities and associated midfoot correction. Bunions are complex three-dimensional deformities that originate from an unstable joint in the midfoot. Treace pioneered and patented the Lapiplasty® 3D Bunion Correction™ System – a combination of instruments, implants and surgical methods designed to correct all 3 planes of the bunion deformity and secure the unstable joint, by attacking the root cause of bunion and helping patients get back to their active lifestyle. Treace recently expanded its offering with the Adductoplasty™ midfoot correction system, designed for reproducible midfoot correction to provide additional support for patients with hallux valgus. For more information, please visit www.treace.com.
On the Journal of foot and ankle surgery
the Journal of foot and ankle surgery is the leading source for original, clinically oriented articles on the surgical and medical management of the foot and ankle.
Trace Medical Notions
Lynn Lewis or Vivian Cervantes