Treace Medical Reports 0.8% Bunion Recurrence at Five Years

Treace Medical Concepts (NASDAQ:TMCI) reported a 0.8% radiographic recurrence rate at five years for its Lapiplasty bunion-correction procedure, according to final ALIGN3D study results announced September 17.

The figure comes with an important qualifier: it applies only when recurrence is defined as a hallux valgus angle greater than 20 degrees. Under a stricter threshold of greater than 15 degrees, recurrence rose to 5.3%. The hallux valgus angle measures big-toe misalignment on an X-ray. Both numbers matter because the definition determines which cases count as failures.

The final analysis included 137 of 173 treated patients, roughly 79% of the original group. Treace also reported clinically meaningful improvements in patient-reported outcomes maintained through the five-year mark.

The commercial question for the company is straightforward: can this evidence persuade more surgeons to adopt Lapiplasty and increase repeat use?

The Bull Case

Five years of follow-up addresses a core concern in bunion surgery: whether correction lasts. Sustained alignment and patient-reported improvement give Treace a stronger foundation for surgeon education than early postoperative results alone.

ALIGN3D was a company-funded, prospective, multicenter study without a comparison group. It involved seven U.S. sites and 13 surgeons. That breadth extends the evidence beyond any single surgeon's practice, though patient selection still matters when applying the findings elsewhere.

Lapiplasty combines instruments, implants, and a surgical technique designed to correct the deformity in three dimensions and stabilize the affected joint. Durable results could help Treace explain the value of that approach to surgeons evaluating competing systems.

Existing surgeon relationships provide a commercial starting point. In the second quarter, approximately 40% of Lapiplasty surgeon users incorporated at least one of three newer bunion systems, up from 35% in the first quarter. That adoption predates the five-year announcement, but it suggests opportunities to deepen usage across the broader portfolio.

The Bear Case

The disclosed analysis does not establish superiority over competing procedures through a randomized comparison. Differences in patient characteristics, surgical technique, and recurrence definitions make comparisons with unrelated studies difficult.

Four-year follow-up and complication details have already been published. The final five-year analysis did not include 36 of the 173 treated patients. Their absence does not establish poor outcomes, but their results could affect the interpretation of durability. Reasons for missing follow-up and endpoint-specific patient counts in the final five-year dataset would help investors assess the evidence.

For Treace, the five-year data gives its salesforce a concrete durability argument. Whether that argument converts into wider surgeon adoption — and deeper penetration of the newer bunion systems — will define the commercial payoff of the ALIGN3D study.