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EditorialFree Access

Heritage must be earned

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    Published Online:1 Mar 2017https://doi.org/10.1302/0301-620X.99B3.BJJ-2017-0150

    Efforts to solve patients’ problems and improve their quality of life can occasionally lead to unexpected and very difficult problems. In this issue, we highlight controversies in relation to bisphosphate treatment, and the atypical fractures that can affect patients in such treatments. Two eminent groups1,2 have summarised their experiences, thoughts and the literature for the benefit of our readership. In contrast, Schilcher et al3 note a potential positive effect of bisphosphonates after cemented total hip arthroplasty. More work is needed in order for us to understand this effect and its implications.4

    The vulnerability of our endeavours is also nicely captured by Paul Beaulé et al5 in relation to the modes of failure after joint preserving surgery of the hip. This is an area that has evolved dramatically over the last three decades,6-8 and there may be an over-eagerness for enthusiasts to apply these techniques to more and more patients. Our increasing ability to identify anatomical abnormalities and minor pathology does not justify an operative procedure in every case.9,10

    We must be careful not to allow improved technology and technique to divert us from our central goal – patient wellbeing and quality of life. Our desire to make progress sometimes leads to a triumph of technique over reason. The exact role and ideal timing for these interventions are yet to be defined.11-19

    The potential for unintended consequences from minor changes is also highlighted by John Skinner’s group20 in their paper on the assessment of the equivalence of a generic to a branded femoral stem. This follows on from a current concepts review we wrote in the BJJ in 2016.21 The potential for generic implants to enter the orthopaedic market has become a serious concern; and the reality may now be coming home to roost as many health systems and organisations feel the need to cut costs. It is, unfortunately easier to do this within a budget year by buying cheaper implants than by looking at the lifetime of a patient and the potential for adverse long-term consequences.

    Generic drugs have been introduced successfully by the pharmaceutical industry. In the world of implants, notably in hip and knee arthroplasty, where minor changes can lead to devastating consequences, it is quite clear that generic implants cannot assume the history of their predecessors. Heritage really must be earned.22-26 The group at University College London20 have elegantly shown that the attempt to copy standard implants that have a good track record is superficially convincing, but that several features are different and could potentially lead to adverse consequences.

    It is certainly possible that some generic implants will work well in a proportion of patients. For example, polished tapered cemented stems generally do well. This, nevertheless, needs to be proved for each individual design. There is an added danger, however, as currently available designs can easily be identified by their radiographic appearance. Copy implants will have a similar radiographic appearance to previous stems, but will have different trunnion geometry and characteristics. Exchange of the femoral head and acetabular component is one of the most common revision operations performed, and could be dangerous in that setting. If a new head – from the original manufacturer – is put onto a retained trunnion of the generic copy implant, we may see avoidable adverse reactions.  There are now several studies reporting taper failures with biologically adverse consequences using metal on polyethylene bearings;27-32 we could inadvertently add to that pipeline. Using unproven implants with no track record as a means of cutting costs presents significant dangers.

    Any discussion about generic implants brings to the fore the issue of how implants should be introduced and evaluated. Several authors, notably Henrik Malchau33,34 and more recently, the IDEAL framework,35 have suggested a stepwise process. Our profession has largely understood this, but often failed to adopt it. We are now in a position where most implant manufacturers and surgeons understand that a new product needs to be evaluated in a relatively closed fashion and observed for a while before widespread use. It needs to be tested with sophisticated techniques that allow the evaluation of early function and pick up early failure, and surrogates of late failure. It can then be subjected to studies that compare its efficacy and safety to standard techniques, and ultimately, can be extended to the population as a whole where observational studies and registry data can allow it to be evaluated further. This is a safe, but slow, process. The advent of registry data and laudable initiatives such as Beyond Compliance,36 have given some industry partners a mechanism to introduce implants to mass use under that banner without any of the critical evaluation that we would expect to see in the scientific literature. That may prove to be a worthwhile route in some cases, but could lead to significant dangers for others. The generic replicas that are entering our market will need a full and thorough stepwise evaluation before they can be considered for routine care.

    We must find a balance between the absolute necessity of improving what we do, and continuing to evolve our interventions and improve them, with the risk that the control mechanisms we put in place are too stifling and lead to stagnation. There is a third danger: of embedding methodologies that rely on observational data and expose patients to risk without appropriate studies in advance. There is little doubt that generic components are going to be popular in some quarters because institutions and surgeons want cheaper implants, and are driven by today’s economic imperatives. On the other hand, patients may pay a big price, and the lessons we have learnt from past attempts at minor change should be adopted and respected.

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