Treace's ALIGN3D bunion study heads toward 5-year data in 2026
Four-year interim results already show recurrence under 8.4% and rapid return to weight-bearing, setting the bar the 5-year readout must hold.
Executive Summary
- Treace Medical Concepts is heading toward the final, longest-follow-up readout of a multi-year study tracking outcomes after its Lapiplasty bunion-correction procedure, extending a run of interim results the company has disclosed since 2021.
- Every interim look at this study through four years of follow-up has shown low rates of the deformity returning and fast recovery of weight-bearing, giving the 5-year data a favorable pattern to either confirm or depart from.
- No trial in the bunion-correction field shares this procedure's mechanism or modality, so the readout's relevance sits mostly within Treace's own portfolio of bunion procedures rather than against a rival program.
- Because the study is non-registrational, the 5-year data will not move a regulatory decision; its value is in supporting the durability claims Treace already makes in its clinical marketing to surgeons.
The study and its purpose
ALIGN3D (NCT03740282) is a prospective, multicenter study tracking outcomes after the Lapiplasty procedure, a 3D bunion-correction technique, in patients with symptomatic hallux valgus. The study enrolled 183 patients across U.S. sites, started in November 2018, and is registered as Not Applicable phase because it evaluates a surgical procedure rather than a drug candidate. It is not a registrational study. The registered primary outcome measure is radiographic recurrence of hallux valgus, and the study has been Active, not recruiting since June 2021 after enrollment closed. NCT03740282Early Weight-Bearing After the Lapiplasty ProcedureNCT03740282
What the interim data show
Treace has disclosed ALIGN3D results at nearly every year of follow-up since 2021. At four years, in 139 patients with at least 4 years of follow-up, the study reported severe radiographic recurrence (HVA greater than 20 degrees) in 0.8% of patients and moderate recurrence (HVA greater than 15 degrees) in 8.4%, average return to protected weight-bearing of 7.7 days, and sustained improvement in pain (81% by VAS) and walking and standing function (89% by MOxFQ). A separate presentation using a 48-month cutoff in a 146-patient analysis found 48-month recurrence of 8.4% by the same threshold, alongside a 95% lower recurrence risk at 48 months in patients whose tibial sesamoid position was corrected to 3 or below at 6 weeks. Treace said in its September 2025 announcement that final patient follow-up for the primary endpoint had already completed in the first half of 2023, and that full study completion with 5-year data is expected in 2026. TreaceTreace Highlights New Product Innovations and Updated Positive Clinical Study Data at the 2025 ...Sep 10, 2025
The registry timeline
The study's registered primary completion date moved three times, from December 2021 to May 2023, then to September 2023, then back to May 1, 2023, all recorded between June 2021 and September 2023. Enrollment was set at 183 actual patients after an original 200-patient target. Those changes predate the current 2026 data-maturation guidance by more than two years, and the study has shown a steady cadence of interim disclosures at conferences in 2021, 2023, 2024, and 2025 in the years since, consistent with an actively followed cohort rather than a stalled program. NCT03740282Early Weight-Bearing After the Lapiplasty ProcedureNCT03740282
The competitive field
No trial identified in the hallux valgus indication shares Lapiplasty's modality or mechanism; the nearest trials in the field test different surgical approaches, implants, or devices, including open wedge osteotomy, degradable metallic hardware, and other 3D correction systems, none of which share Lapiplasty's specific technique. Treace's own related study of the Adductoplasty procedure, a combined bunion-correction approach, is the only other program under the same sponsor tracked against this indication. That isolation means the 5-year ALIGN3D data will mainly extend Treace's own durability evidence base for surgeons rather than settle a question relative to a competing mechanism.
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