Bioabsorbable vs. titanium screws in first metatarsophalangeal joint arthrodesis: a pilot randomized controlled trial with 2-year follow-up.

INTRODUCTION

To assess the feasibility and preliminary clinical outcomes of bioabsorbable screw fixation in first metatarsophalangeal joint arthrodesis compared to conventional titanium screw fixation.

METHODS

In this prospective pilot randomized controlled trial, 30 patients were allocated 1:1 to bioabsorbable or titanium cannulated lag screw fixation. Arthrodesis was performed using a cup-and-cone technique at two Finnish hospitals. Full weight-bearing in an orthopaedic shoe was allowed after six weeks. Outcomes included AOFAS and VA-FAS FA-VAS scores, union rates, and complications assessed at 3, 6, 12, and 24 months.

RESULTS

Both groups showed significant functional improvement with no between-group differences. At 24 months, mean AOFAS scores were 89.1 (SD 2.7) in the titanium group and 90.0 (SD 0.0) in the bioabsorbable group (p = 0.23). Mean FA-VAS total scores (sum of pain, function, and complaints subscales) were 1948 (SE 59.4) in the titanium group and 1914 (SE 61.4) in the bioabsorbable group (p = 0.655). Union rate was 90% overall; nonunion occurred in one titanium and two bioabsorbable patients, all requiring revision. No implant-related complications or hardware removal surgeries were recorded. Degradation of bioabsorbable screws caused no adverse clinical or radiographic reactions.

CONCLUSIONS

Bioabsorbable screws appear safe and feasible in first metatarsophalangeal joint arthrodesis, with preliminary outcomes comparable to titanium fixation. These findings support the conduct of a larger confirmatory trial.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT03133039, registered 28 April 2017. https://clinicaltrials.gov/ct2/show/NCT03133039.