Treace Announces Updated Interim Analysis From The ALIGN3D Clinical Study at the 2022 American Orthopaedic Foot & Ankle Society Annual Meeting
PONTE VEDRA, Fla., Sept. 13, 2022 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. ("Treace") (NASDAQ:TMCI), a medical technology company driving a fundamental shift in the surgical treatment of hallux valgus
PONTE VEDRA, Fla., Sept. 13, 2022 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. ("Treace") (NASDAQ:TMCI), a medical technology company driving a fundamental shift in the surgical treatment of hallux valgus (commonly known as bunions) through its Lapiplasty® 3D Bunion Correction™ procedure, today announced an audio poster presentation of the latest interim analysis from the ALIGN3D™ clinical study at the ongoing 2022 American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting in Quebec City, Canada.
The audio poster, "Radiographic and Patient Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing: Interim Analysis of a Prospective Multicenter Study (ALIGN3D)", included the interim analysis of 159 patients (of 173 total patients treated) with at least 12 months of follow-up following the Lapiplasty® Procedure. The data showed:
- Early return to weight bearing in a walking boot at an average 8.3 days;
- Low recurrence rate, defined as loss of radiographic correction, was observed in 1.4% of patients (2 out of 144 patients); and
- An 81% reduction in pain (Visual Analog Scale) was reported at 24 months post-procedure (n=107).
The interim analysis also continued to report statistically significant improvement in Patient-Reported Outcomes (PRO) across two validated scoring systems, including the Manchester-Oxford Foot Questionnaire (MOxFQ) and the Patient Reported Outcomes Measurement Information Systems (PROMIS-29). At 24 months post-surgery (n=107), an 82% and 84% improvement was observed in walking/standing as well as social interaction, respectively, using the MOxFQ scoring system. Further, statistically significant improvement in physical, mental, and social health scores were reported using the PROMIS-29 scoring system (n=104).
John T. Treace, CEO, Founder and Board Member of Treace said, "Interim data readouts from our ongoing ALIGN3D™ clinical study continue to demonstrate sustained, successful procedural and patient outcomes on additional patients followed through 12-, 24- and 36-months post-surgery. This type of multicenter, prospective study is unique in the field of bunion surgery, and reflects our commitment to investing in clinical programs, building upon our differentiated body of clinical evidence, as we advance the Lapiplasty® Procedure as the standard of care for bunion surgery."
The audio poster, which includes additional details, can be accessed by meeting attendees on a kiosk at the Annual Meeting or on the mobile app. The updated data is also available on the Treace Medical website.