Welcoming Clinical Trial Protocols to Foot & Ankle Orthopaedics

Foot & Ankle International and Foot & Ankle Orthopaedics are committed to advancing rigorous, patient‑centered research that improves orthopaedic care.

Foot & Ankle Orthopaedics will now publish peer-reviewed protocols for randomized or other prospective interventional trials that address important foot and ankle questions. By providing an openly accessible blueprint of each study’s objectives, methods, and statistical analysis plan, we aim to foster transparency, encourage collaboration, and strengthen the evidentiary foundation on which future practice guidelines will be built.

Publication of protocols benefits everyone involved. Investigators receive early, citable credit for the intellectual work invested in meticulous trial design; clinicians and methodologists can critique and refine trial methods while changes are still feasible; and the wider research community gains an auditable public record that curbs selective reporting and publication bias. These advantages align with best practice guidance from the EQUATOR Network and complement our journals’ missions of methodologic excellence.

To balance the advantages of openness with editorial responsibility, we will accept only protocols that meet the following benchmarks:

1. Prospective registration

2. Documented ethics approval

3. Completed SPIRIT 2025 checklist and accompanying SPIRIT schedule figure ¹

4. Dated statistical analysis plan

5. ICMJE-compliant data-sharing statement

6. Conflict of interest disclosures:

7. b. Every protocol must disclose the role of trial sponsor and funders, if any, in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.

Each manuscript will undergo review by a biostatistician and/or Associate Editor using an FAO checklist mapped to SPIRIT items and our Instructions for Authors for Clinical Trial Protocols (https://journals.sagepub.com/author-instructions/FAO). Acceptance will be conditional on the authors’ commitment to update the trial registry for every amendment and to submit primary results to FAI or FAO within 12 months of study completion.

We believe this policy will elevate the quality, credibility, and impact of future trials that shape foot and ankle care. Following critical review and discussion within the Editorial Board, we are pleased to contemporaneously publish our first protocol, “The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures: Patient-Reported Functional Outcome and Radiological Stability Measurements: A Clinical Trial Protocol.” ² We hope this is the first of many.

Charles L. Saltzman, MD Robert B. Anderson, MD Brad D. Blankenhorn, MD John T. Campbell, MD Timothy R. Daniels, MD, FRCSC Ellie Pinsker, PhD Stefan Rammelt, MD, PhD Robert A. Vander Griend, MD