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How should new orthopaedic implants be introduced: an example and recommendations for best practice.

Richard Hannan1, Varun Arora1, Richard Beaver2

  • 1Department of Orthopaedics, Royal Hobart Hospital, Hobart, Tasmania, Australia.

ANZ Journal of Surgery
|November 11, 2017
PubMed
Summary

New orthopaedic implants require rigorous evaluation before clinical use to ensure patient safety and avoid costly failures. Implementing staged assessments by high-volume surgeons in specialist centers is crucial for evidence-based innovation.

Keywords:
arthroplastybiomedicaldiffusion of innovationimplantsorthopedics, prosthesestechnology assessment

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Area of Science:

  • Orthopaedic surgery
  • Biomedical engineering
  • Medical device regulation

Background:

  • Rapid advancements in orthopaedic implants often outpace evidence of safety and efficacy.
  • Publicized failures highlight risks associated with inadequately tested medical devices.
  • Harm to patients could be mitigated through structured introduction of new technologies.

Purpose of the Study:

  • To review optimal practices for introducing new orthopaedic technology.
  • To analyze lessons learned from the ESKA Adapter Short-stem/Modular Hip failure.
  • To propose a framework for evaluating orthopaedic implants.

Main Methods:

  • Literature review on the introduction of new orthopaedic technology.
  • Case study analysis of a specific failed hip implant (ESKA Adapter Short-stem/Modular Hip).
  • Discussion of evaluation methodologies including biomechanical studies, radiostereophotometric analysis, and implant retrieval.

Main Results:

  • Current practices often lack sufficient evidence base for new orthopaedic implants.
  • The ESKA Adapter failure illustrates critical gaps in evaluation and reporting.
  • A structured approach involving high-volume surgeons and specialist centers is recommended.

Conclusions:

  • Optimal practice necessitates comprehensive evaluation of new orthopaedic implants before widespread adoption.
  • Early reporting of results and complications to registries and regulatory bodies is essential.
  • A balanced approach can protect patients while fostering surgical innovation.