August 24, 2012
3 min read

International metal-on-metal hip arthroplasty guidelines needed to guide patient care

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Patients around the world with metal-on-metal hip prostheses have raised valid concerns about the problems they may face in the future. Orthopaedic surgeons also have their own questions about this controversial situation.

Of concern to both parties is the true extent of the health risks faced by patients with total or resurfacing metal-on-metal (MoM) hip arthroplasty bearings. As these risks can change over time, orthopaedic surgeons worldwide need clear guidance on the correct steps to take during the follow up of these patients. Which clinical follow-up measures should be used? What imaging is most appropriate and when should it be performed?

Testing patients for metal ion levels is among those unanswered questions. Orthopaedists want to know exactly what the highest acceptable levels of blood and serum cobalt and chromium are and when revision surgery is indicated. However, clear guidance about the best tests to use and which steps should be taken is still lacking.

Per Kjaersgaard-Andersen 

Per Kjaersgaard-Andersen

In the United States, a panel of experts recently met at the request of the U.S. Food and Drug Administration to address these concerns. The panelists nearly all agreed on the importance of metal ion level testing, but they did not set any safe upper limits for the levels. They also discussed the important role imaging plays in following up patients with MoM resurfacing or total hip arthroplasty, although no standards were set in this area either.

Guidelines for consistent care

Given the seriousness of the MoM situation worldwide, international guidelines must be developed now. Joint replacement surgeons who manage patients with MoM hip prostheses are eager for the guidelines.

There are some key advantages to having international MoM arthroplasty guidelines. They would foster a unified approach to care across all cases and would supersede guidelines proposed by hospitals, centers, countries and orthopaedic organizations. Having international guidelines that everyone is requested to follow would also reduce the chances that data for current MoM cases are misinterpreted by health authorities.

Clear guidelines also may help the media understand the current situation and better interpret any future decisions that health care organizations and governments make about MoM joint replacement surgery.

On April 2, the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) published a statement about MoM hip bearings. On April 16, a multidisciplinary international panel of experts endorsed by EFORT and the European Hip Society, the German Arbeitsgemeinschaft Endoprothetik and the Deutsche Arthrosehilfe met and created its own recommendations for the management of patients with MoM hip replacements, entitled “Current Evidence on the Management of Metal-on-Metal Bearings.”

The panel’s recommendations, based on updated literature on the subject, addressed the relevant aspects of the daily management of patients with MoM bearings. This consensus statement was published at the EFORT website, and EFORT updated its statement on the MoM situation on July 2. Taken as a whole, both statements demonstrate that international guidelines are needed so that orthopaedic surgeons can manage their patients with MoM hip arthroplasty in a more consistent manner.

Who creates the guidelines?

There is some debate about who should set such guidelines and whether overarching guidelines, such as these, will actually be followed. These are relevant concerns given the MoM situation and the potential impact of the recommendations. Several national orthopaedic societies have their own national guidelines for a range of orthopaedic topics, which shows that overall guidelines can be developed and implemented successfully.

However, Europe-wide guidelines for MoM prosthesis management would have a broader impact. They may be more challenging to establish since there are currently no Europe-wide guidelines for basic or advanced orthopaedic treatments of any kind. I think EFORT could be a leader in this area as it has received positive feedback from national orthopaedic societies on its MoM and the expert panel consensus statements.

The worldwide MoM hip bearing debate and the urgent, unresolved questions about how to follow up patients with the implants are an opportunity for EFORT officials to approach European Union (EU) politicians in Brussels. EFORT is well-positioned to ask for EU assistance to create European guidelines for musculoskeletal care. For our patients’ sake, we need to develop effective guidelines regarding the current MoM arthroplasty situation.