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

Continued advancements in orthopaedics have led to the development of many new implants; many of these are being utilized in clinical practice with little or no evidence base for their safety or effectiveness. Highly publicized failures in orthopaedic technology have led to an increased awareness of this issue in both medical and non-medical circles. In most cases, the significant harm caused to the public could have been avoided by the appropriately staged implementation of new implants. This review comments on the current literature regarding the optimal practice for the introduction of new orthopaedic technology. The authors' experience with the failed ESKA Adapter Short-stem/Modular Hip is described; the methodology used for its evaluation is used as a basis to discuss what was successful about the process and also give warning on what could be improved upon. The ideal practice requires new orthopaedic implants to be evaluated by high-volume surgeons in specialist orthopaedic hospitals. These studies should include biomechanical studies, radiostereophotometric analysis, implant retrieval and outcome assessment. Results and complications should be reported early to the appropriate joint registry and regulatory body. Once a suitable evidence base has developed, the implant can be distributed into wider clinical practice or withdrawn. These recommendations aim to protect the patient and public from harm while allowing surgical innovation to still continue.