Abstract
No, not my mother, but metal-on-metal (MoM) hips! My involvement in the DEFENSE side of MoM hips has allowed me the luxury of reflection and continued study on the basic and clinical science of this particular wear couple. Much of what I have learned is relevant to other articular couples, and might help you in your next THR.
No amount of in vitro laboratory testing can replicate or predict in vivo behavior of a particular wear couple. (Mother Nature always has something new to teach us!) Although MoM implants went through complete pre-market evaluation and approval in both the US and EU, the process is inadequate and does not assure safety or success of new designs and materials. Two year results obtained in pre-market (IDE) studies are of insufficient follow-up for accurate evaluation of new materials or designs. Be conservative! Be neither the first, nor the last, to embrace new technology!
Clinical experience and retrieval analysis of MoM devices has revealed factors that are not as apparent for other wear couples such as metal-on-polyethylene (MoP), or ceramic-on-ceramic (CoC). For instance:
All THR's are at risk of micro-lateralization, or displacement of the femoral head from the acetabular wear couple during swing phase, resulting in edge loading. In addition, impingement or displacement related to component malposition or failure to balance the soft tissues about the hip can produce subluxation, producing edge loading and accelerated wear. In the case of MoM implants, the tribology and wear properties of MoM produce identifiable wear scars; all MoM designs appear to be subject to these phenomena. However, evidence now exists that both MoP and CoC wear couples are at similar risk for accelerated wear, although at different rates than MoM.
Hard-on-hard wear couples (ceramic, metal) are less tolerant of edge loading than hard-on-soft (e.g., MoP or CoP) wear couples, and therefore require a higher degree of surgical precision in implant placement and reconstruction of the soft tissue balance of the hip.
One of the previously unrecognised factors that can change relative implant position (and therefore, the risk of subluxation or edge loading) is the effect of the lumbar spine on apparent acetabular component position (e.g., changes between sitting, standing, or lying prone). This is largely due to the effect of lumbar spine flexibility, as shown in both orthogonal x-ray (“EOSr”) studies, and dynamic CAT scan studies. There is currently no validated algorithm or technique to assess these factors; however, surgeon awareness and at least clinical assessment preoperatively may result in better positioning of implants. Femoral component position can also have a major effect of the risk of impingement or subluxation of the femoral head; the combined anteversion concept of Dorr et al. should be rigorously adhered during THR.
Other issues such as fretting corrosion associated with large diameter femoral heads and tissue response to wear debris may not be anticipated until a very large cohort population is available for examination and analysis.
No matter how extensive in vitro testing may be, only clinical experience and retrieval analysis can provide the ultimate reassurance as to the success of a new design or material.
