Richard Hannan ,* Varun Arora,* Richard Beaver† and Paul Harvie*
*Department of Orthopaedics, Royal Hobart Hospital, Hobart, Tasmania, Australia and
†Department of Orthopaedics, Royal Perth Hospital, Perth, Western Australia, Australia
Abstract
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Once a suitable evidence base has developed, the implant can be distributed into wider clinical practice or withdrawn.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.
Key words
arthroplasty, biomedical, diffusion of innovation, orthopedics, prostheses, implants, technology assessment.
Introduction
Orthopaedic implants and their regulation has been a topical discussion in recent years,1–3 both in medical circles as well as in the media.
The failure of some metal on metal hip replacements such as the DePuy ASR (DePuy, Warsaw, IN, USA)4–6 has been widely reported in the media leading to a greater interest in implant safety from both patients and the general public.
Increasingly, in Australia, surgical innovation is occurring without an adequate evidence base to support it. 3 From years 2000 to 2011, there were nearly 300 deaths and over 2000 serious injuries related to medical devices in Australia. 7 The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) was in part set up to identify and flag prostheses that have a higher than expected revision rate. 8,9 Two of the most recent Australian Orthopaedic Association annual scientific meetings (2012 and 2014)10 have had the regulation and evidence for orthopaedic implants as theme topics.
A 2011 analysis of the AOANJRR showed that no hip or knee arthroplasty introduced in Australia between 2003 and 2007 had improved outcomes over those currently being used. Of those introduced, 30% were associated with significantly worse outcomes. 11 Other studies worldwide have shown a similar link with poorer outcomes being associated with new arthroplasty designs. 12–14 Australia is not alone in this issue. The 2013 National Joint Registry of England, Wales and Northern Ireland reported that of the 86 488 implanted hip arthroplasties in the UK in 2012, only 69% of uncemented stems and 3% of uncemented cups met the UK Orthopaedic Data Evaluation Panel benchmark rating. 15 Nearly one-fourth of all hip replacement implants available in the UK have no evidence at all for their clinical effectiveness. 16 The risks of using implants with little evidence available to support their clinical effectiveness need to be evaluated against the perceived technological benefits. Innovation should be encouraged; however, clearly defined and nationally recognized strategies should exist to bring new implants into the public/patient domain with patient safety and protection being the major prerequisite.
For the purpose of this commentary, a review of the literature was undertaken. With this information and using the authors’ experience in Australia with the ESKA Adapter Short-stem/Modular Hip (EAH) (ESKA, Lubeck, Germany), this paper provides recommendations for how new implants should be introduced. The journey from initial concept through to the final withdrawal of this stem is described and the process is used as a basis to give advice (as well as warning) on the optimal methodology for the introduction of new orthopaedic implants, both in Australia and worldwide.
Full publication here
Correspondence
Dr Richard Hannan, Department of Orthopaedics, Royal Hobart Hospital, 48 Liverpool Street, Hobart, TAS 7000, Australia. Email: rjhannan@gmail.com
R. Hannan MBBS; V. Arora MBBS; R. Beaver
FRACS; P. Harvie FRCS (Tr & Orth), MD.
Accepted for publication 14 August 2017.
doi: 10.1111/ans.14234