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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
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.
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.
