Authors
Martin McNally, Maria Dudareva, Michelle Kümin, Werner Vach, Claire L Scarborough, Matthew J Cichero, Ricardo Sousa, Jamie Ferguson, David A Stubbs, Bridget L Atkins, Alex J Ramsden, Bernadette C Young, Andre D Carvalho, Adrian R Kendal, Abtin Alvand, Antony J R Palmer, Con L Loizou, Ben Kendrick, Adrian H Taylor, Amirul Islam, Michael J Riste, Anand Pillai, Sunil K Sharma, Jonathan Folb, Neal Jacobs, Simon C Ellis, Aaron B Y Ng, Daniel Perez-Prieto, Irene K Sigmund, Reinhard Windhager, Alexis D Iliadis, Andrew J F Bing, Henry Wynn Jones, John Williams, Ben J Ollivere, Volker Alt, Simon Warren, Neil E Jenkins, Andreas Leithner, Harriet C Hughes, Steve A Jones, O Martin Williams, Matthew Scarborough
Published in
The New England journal of medicine. Sep 16, 2026. Epub Sep 16, 2026.
Abstract
Orthopedic infection is usually managed with surgery and prolonged systemic antibiotic therapy. Whether local antibiotics delivered by a product implanted at the infection site during surgery can reduce the duration of systemic antibiotic therapy is unclear.
In a multicenter, open-label, noninferiority trial, we randomly assigned, in a 1:1 ratio, adults who had undergone surgery for orthopedic infection and implantation of a local-antibiotic carrier to receive postoperative systemic antibiotic therapy for a long (≥4 weeks) or short (≤7 days) duration. The primary outcome was definite treatment failure by 12 months, assessed according to protocol-defined criteria by a clinical end-point committee whose members were unaware of the trial-group assignments. The noninferiority margin was 10 percentage points.
A total of 500 patients underwent randomization, of whom 475 were assessed in the primary analysis. Definite treatment failure occurred in 34 of 241 patients (14.1%) in the long-duration group and in 26 of 234 patients (11.1%) in the short-duration group (risk difference [negative values favor the short duration], -3.0 percentage points; 95% confidence interval [CI], -9.0 to 3.0), which met the prespecified noninferiority margin. In sensitivity analyses in the included population (497 patients) and the per-protocol population (457 patients), results were consistent with those of the primary analysis (risk difference, -2.4 percentage points [95% CI, -8.2 to 3.5] and -2.7 percentage points [95% CI, -8.8 to 3.4], respectively). By week 6 after surgery, symptoms potentially related to treatment had occurred in 45.2% of the patients in the long-duration group and in 17.2% of those in the short-duration group (risk difference, -28.0 percentage points; 95% CI, -36.4 to -19.6).
Among patients who had undergone orthopedic surgery and received local antibiotics, a short course of systemic antibiotics was noninferior to a long course with respect to definite treatment failure by 12 months. (Funded by the European Bone and Joint Infection Society and others; SOLARIO ClinicalTrials.gov number, NCT03806166.).
PMID:
42748421
Bibliographic data and abstract were imported from PubMed on 17 Sep 2026.
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