Treace Medical reports 5-year Lapiplasty data at AOFAS 2026

Treace Medical Concepts has presented results from three prospective clinical studies at the American Orthopaedic Foot & Ankle Society annual meeting in Seattle, led by five-year follow-up data from its ALIGN3D Lapiplasty programme. The Florida-based medical technology company said the data collectively reinforce the durability of its triplanar bunion correction approach across multiple product lines.

The headline dataset covers 137 of the 173 patients originally enrolled in the ALIGN3D study, a prospective multicentre US trial evaluating the Lapiplasty 3D Bunion Correction System for symptomatic hallux valgus. At the five-year mark, the study recorded a radiographic recurrence rate of just 0.8% using a hallux valgus angle threshold of greater than 20 degrees, rising to 5.3% when the stricter threshold of greater than 15 degrees was applied. Patients returned to weight bearing in a walking boot at an average of 8.4 days post-procedure, and clinically significant improvements in patient-reported outcome scores on the MOxFQ and PROMIS instruments were maintained throughout the full follow-up period.

Trial readouts

The second dataset covers the MTA3D Adductoplasty programme, which combines metatarsus adductus correction with the standard Lapiplasty procedure. Interim two-year data from 59 of 66 enrolled patients showed an average weight-bearing return of 7.6 days, with radiographic correction of both midfoot and hallux valgus deformity maintained at 24 months. Pain and quality-of-life scores on VAS, MOxFQ, and PROMIS scales improved significantly and held through the two-year timepoint. The study is expected to reach its primary endpoint with full cohort follow-up.

The third presentation covered the SPRINT SpeedPlate observational study, a one-year multicentre assessment of the company's dynamic compression implant system in 89 of 91 treated patients following metatarsophalangeal or tarsometatarsal joint arthrodesis. Clinical and radiographic union was achieved in 96.6% of patients at 12 months, and radiographic correction measures were significantly improved at six weeks and maintained through to the 12-month endpoint. Return to weight bearing averaged 9.0 days.

Market context

Bunion surgery is a relatively high-volume segment of orthopaedic foot and ankle practice. Treace estimates approximately 67 million Americans live with bunions and that around 1.1 million are surgical candidates annually, making it a commercially meaningful target market. The company has positioned Lapiplasty as a differentiated approach versus traditional two-dimensional osteotomy techniques, on the basis that triplanar correction addresses the underlying joint instability rather than the visible bony prominence alone.

The five-year ALIGN3D follow-up is notable in a market where long-term prospective data for proprietary surgical systems remain relatively scarce. Competing approaches, including minimally invasive osteotomy techniques from a number of device companies, are growing in adoption, and durability data beyond two or three years can become a meaningful differentiator in purchasing decisions by hospital systems and ambulatory surgical centres. Treace itself offers minimally invasive variants in its own portfolio, namely the Nanoplasty and Percuplasty systems, suggesting the company is hedging across surgical preferences.

The full presentations, including complication rates, patient demographics, and inclusion and exclusion criteria, are due to be made available on Treace's website following the conference.