Surgery Versus Watchful Waiting for First Metatarsophalangeal Joint Osteoarthritis : A Randomized Controlled Trial.

Hallux rigidus, or osteoarthritis of the first metatarsophalangeal joint (MTPJ), causes pain and functional limitation. No randomized trials have compared surgery with the natural course of the disease.

To compare first MTPJ arthrodesis-a widely used surgical intervention-with watchful waiting in reducing walking-related pain in symptomatic hallux rigidus at 12 months after randomization.

Single-center, parallel-group, randomized, controlled, superiority trial with 12-month follow-up. (ClinicalTrials.gov: NCT04590313).

Orthopedic department of a tertiary care hospital in Finland.

Adults aged 40 years or older with radiographically confirmed (Coughlin-Shurnas grade I to III) hallux rigidus with symptoms over a year and a walking pain score of 4 or higher on a numerical rating scale (NRS) of 0 to 10 were eligible. Exclusion criteria included type 1 diabetes mellitus, rheumatoid arthritis, and hallux valgus angle greater than 15°.

Participants were randomly assigned in a 1:1 ratio to surgery with first MTPJ arthrodesis using lag-screw and dorsal plating or to watchful waiting.

The primary outcome was walking-related pain (NRS of 0 to 10) at 12 months. The prespecified minimal clinically important difference was 1.7 points.

Between November 2021 and June 2024, 90 patients were randomly assigned (45 per group). The mean age was 58.1 years, and 89 participants completed the 12-month follow-up. At 12 months, the observed mean walking-related pain was 1.3 in the arthrodesis group and 5.7 in the watchful waiting group (adjusted mean difference, -5.0 points [95% CI, -6.1 to -3.9 points]), exceeding the prespecified minimal clinically important difference and favoring arthrodesis.

Single-center design.

Among adults aged 40 years or older with painful hallux rigidus, first MTPJ arthrodesis provides a superior and clinically significant reduction in walking-related pain at 12 months compared with watchful waiting.

Suomen Lääketieteen Säätiö Foundation, Finland.