Treace Medical Concepts has released three-year interim clinical results from its ALIGN3D post-market trial as per which the Lapiplasty 3D Bunion Correction procedure delivered sustained, positive outcomes during bunion treatment.
The prospective, five-year, multicentre ALIGN3D study recruited 173 patients who were assessed following the Lapiplasty procedure for surgical management of symptomatic hallux valgus.
The primary effectiveness endpoint was defined as radiographic recurrence of the hallux valgus deformity at 24 months follow-up.
According to the findings, the patients showed an early return to weight bearing in a walking boot at an average of 8.4 days.
The radiographic recurrence rates were low during the latest visit of 0.9% using HVA>20° and 5.2% using HVA>15°.
The three-year data also revealed an 81% reduction in pain measured using the Visual Analog Scale (VAS) at 24 months.
Additionally, there was an 86% improvement in walking/standing and an 85% improvement in social interaction patient-reported quality of life measures.
Furthermore, there were major improvements in patient-reported outcomes across all Patient-Reported Outcomes Measurement Information System domains over time through the latest subject visit.
Treace Medical Concepts CEO, founder, and board member John Treace said: “We are pleased that this three-year data from our prospective, multicentre ALIGN3D study continues to demonstrate sustained, successful patient outcomes from our proprietary Lapiplasty Procedure.
“We believe these three-year clinical study results set a high standard for a commercial bunion technology and one that further differentiates Lapiplasty in the marketplace with our surgeons and their patients.
“We look forward to continuing to expand our market-leading body of clinical evidence, as we advance the standard of care for bunion surgery.”
Based in the US, Treace Medical Concepts is focused on advancing the surgical management of bunion and associated midfoot deformities using its flagship Lapiplasty and Adductoplasty procedures.
The Lapiplasty 3D Bunion Correction system is designed to surgically correct all three planes of the bunion deformity and secure the unstable joint. It is a combination of instruments, implants, and surgical methods to address the root cause of the bunion and support patients in regaining their active lifestyles.
