Guidance on the use of metal on metal hip resurfacing arthroplasty
This is an extract from the guidance. The complete guidance is available at guidance.nice.org.uk/ta44
1 Guidance
|
In June 2012 the advice about the follow-up of people with metal on metal hip replacements changed (see medical device alert MDA/2012/036 from the Medicines and Healthcare products Regulatory Agency [MHRA]). |
1.1 Metal on metal (MoM) hip resurfacing arthroplasty is recommended as one option for people with advanced hip disease who would otherwise receive and are likely to outlive a conventional primary total hip replacement. In considering hip resurfacing arthroplasty, it is recommended that surgeons take into account activity levels of potential recipients and bear in mind that the current evidence for the clinical and cost effectiveness of MoM hip resurfacing arthroplasty is principally in individuals less than 65 years of age.
1.2 When MoM hip resurfacing arthroplasty is considered appropriate, the procedure should be performed only in the context of the ongoing collection of data on both the clinical effectiveness and cost effectiveness of this technology. Ideally, this data collection should form part of a UK national joint registry.
1.3 This guidance should be read in conjunction with the Institute's guidance on devices for total hip replacement (Guidance on the selection of prostheses for primary total hip replacement: NICE Technology Appraisal Guidance No 2. April 2000). In that guidance, the Institute recommended that the best prostheses (using long-term viability as the determinant) should demonstrate a 'benchmark' revision rate (the rate at which they need to be replaced) of 10% or less at 10 years or, as a minimum, a 3 year revision rate consistent with this 10-year benchmark. Establishing and confirming similar benchmarking criteria will be necessary for MoM hip resurfacing arthroplasty and will be facilitated by a UK national joint registry. In the interim, the 3 year minimum benchmark should apply to MoM hip resurfacing devices.
1.4 MoM hip resurfacing arthroplasty should be performed only by surgeons who have received training specifically in this technique.
1.5 Surgeons should ensure that patients considering MoM hip resurfacing arthroplasty understand that less is known about the medium- to long-term safety and reliability of these devices or the likely outcome of revision surgery than for conventional total hip replacements. This additional uncertainty should be weighed against the potential benefits claimed for MoM devices.