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A practical guide to the implementation of AI in orthopaedic research-Part 4: Prerequisites for a successful orthopedics AI-driven project in terms of interdisciplinary collaboration, data management, ethical approval and technology

  • Umile Giuseppe Longo
  • , Mario Merone
  • , Emiliano Schena
  • , Benedetta Bandini
  • , Guido Nicodemi
  • , Bálint Zsidai
  • , Ann Sophie Hilkert
  • , Eric Hamrin Senorski
  • , Alberto Grassi
  • , Christophe Ley
  • , Elmar Herbst
  • , Michael T. Hirschmann
  • , Sebastian Kopf
  • , Romain Seil
  • , Thomas Tischer
  • , Robert Feldt
  • , Kristian Samuelsson*
  • , Felix C. Oettl
  • *Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

Abstract

UNLABELLED: Translating artificial intelligence (AI) research in orthopedics from proof-of-concept studies into production-grade clinical systems requires the systematic satisfaction of four prerequisite domains: interdisciplinary team architecture, technical data management, ethical and regulatory governance and production-grade technology and deployment infrastructure. Despite a tenfold increase in orthopedic AI publications, fewer than 6% of studies reach routine clinical deployment, reflecting persistent gaps in each of these domains. This article provides a technically rigorous, evidence-based framework organized around these four pillars. The interdisciplinary team may be structured using a product-centric topology that decouples stream-aligned clinical teams from platform infrastructure teams, following Huffman et al.'s six-step AI project lifecycle: obtain/curate/label data; establish a reference standard; develop the model; evaluate performance; externally validate and iteratively reinforce until clinical implementation is viable. Data management requires data extraction protocols, integration for bulk exports and a multi-component de-identification pipeline. A multi-stage Institutional Review Board framework governs ethical oversight, scaling from Exempt review for retrospective de-identified studies to Full Board Review with prospective validation and mandatory human-override mechanisms for interventional deployment. Responsible clinical deployment requires a multi-layer Clinical Machine Learning Operations framework, implementing privacy-preserving deployment, clinical observability, compliance audit trails and human-in-the-loop governance. Model drift has to be monitored with a degradation threshold triggering mandatory human review.

LEVEL OF EVIDENCE: Level V.

Original languageEnglish
Article numbere70863
JournalJournal of Experimental Orthopaedics
Volume13
Issue number3
DOIs
Publication statusPublished - Jul 2026
Externally publishedYes

Keywords

  • artificial intelligence
  • collaboration
  • management
  • structure

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