Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies
The systematic review supervised by Art Sedrakyan, vice-chair of IDEAL aimed to address a key question of the evidence base for widespread introduction of five recent, well known, and ostensibly high value implantable device technologies in total hip and knee replacement.
The authors did not find strong and quality evidence supporting the adoption and use of these technologies—in fact they found that earlier alternative devices may be safer.
The authors systematically searched and appraised the evidence including grey data sources and compared the new implants with the closest conventional, well established, equally suitable alternatives.
They reviewed all relevant safety and effectiveness endpoints in 118 published studies that reported data on 15,384 implants from 13,164 patients. They also reviewed data in registry reports that include over a million patients.
None of the reported comparative data show improved ‘survival’ for these devices. And there were higher repeat surgery rates associated with three leading technologies.
The authors did not intend to criticise the surgical community or orthopaedic industry. The study highlighted that ‘status quo’ regarding the introduction of new device technologies is no longer acceptable. The stakeholders should not assume that metal on metal device failure in hip replacement was an isolated phenomenon. With hundreds of thousands of devices on the market and widespread introduction without evidence consideration there is a potential for technologies to get widely used and lead to massive patient harms. In the age of direct to consumer advertisement substantial efforts are needed by all stakeholders to invest in systems of careful evaluation. This will help to promote controlled and evidence based introduction of device innovations.
One good example of such practice is ‘beyond compliance’ program in the UK (http://www.beyondcompliance.org.uk/) . The registries and registry consortia, such as the International Consortium of Orthopaedic Registries (www.icor-initiative.org) are critical developments to address safety in real world but they have limited influence on the paths and loopholes associated with introduction of device related technologies on the commercial market.
The authors suggest adherence to the IDEAL recommendations such as ‘licensing with evaluation’ and when clinically relevant improvements have not been convincingly shown widespread commercial introduction should be deferred until appropriate long term safety comparable to existing technologies has been demonstrated. (See specific recommendations directed at regulators below)
IDEAL recommended actions to facilitate improvements in surgical evidence
• Promotion of IDEAL reporting and design standards
• Assistance by editors with development of registries of surgical protocols and reports
• Calls for specific prospective study designs
Funders (both service and research)
• Provide specific funding for well-designed early-stage surgical innovation
• Demand evidence of benefit for new techniques
• Link funding to adequate scientific evaluation
• Support well-designed surgical databases, registries, and reporting systems
• Provide rapid, flexible, and expert ethical oversight for early-stage innovation
• Link provisional approval to evaluation or registration of all cases
• Accept IDEAL approved study designs as evidence of appropriate evaluation
• Raise burden of proof for full licensing of new devices to demonstration of efficacy
• Ensure guidelines explicitly support IDEAL model of technical development and evaluation
• Require members to use appropriate registers for the various stages of innovation as a condition of specialist recognition
From: McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12
Link to full systematic review:
Nieuwenhuijse MJ, Nelissen RG, Schoones JW, Sedrakyan A. Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies. BMJ. 2014 Sep 9;349:g5133