Prof. Dr. Carsten Perka, Scientific Director of the EPRD and Spokesperson of the Executive Committee

“It could become the best register in the world.”

Due to the “traffic light” vote, a lot of work has been left undone in Berlin. Now, under the leadership of the new Federal Minister of Health, Nina Warken (CDU), the question arises: What will happen next with the planned Implant Register Germany (IRD)? And what does this mean for the established Endoprosthesis Register Germany (EPRD)? We spoke with Prof. Dr. Carsten Perka, Charité Universitätsmedizin Berlin, in his role as Scientific Director and Spokesperson of the EPRD Executive Committee, about the current status.

EPRD Success Story

The EPRD is undisputedly a success story. Launched by the German Society for Orthopedics and Orthopedic Surgery, the AOK Federal Association, the Association of Statutory Health Insurance Funds, and the Federal Association of Medical Technology, the registry has been collecting and analyzing data on hip and knee replacements in Germany since 2012. With more than three million documented cases, the EPRD is considered the third-largest joint replacement registry in the world. “Based on this data, we have been able to contribute to research with over 30 publications and provide reliable user recommendations. The approximately 760 participating clinics receive clinical evaluations several times a year to monitor their treatment quality, and the manufacturers receive individual performance data on their own products,” says Prof. Perka, summarizing the registry’s services.
Given the high scientific importance, the registry’s original purpose is almost lost sight of: an early warning system for implant failure. “We simply didn’t have our own data in Germany on metal-on-metal hip replacements and couldn’t adequately argue the case, even though Australian statistics, for example, had long reported above-average revision rates,” Prof. Perka recalls the registry’s beginnings. “Even with an A2® short-stem system, we want to know how it performs in widespread use.” Excellent results in a clinic with a system, as provided by studies, are simply not equivalent to success in widespread “real-world” use. Today, thanks in part to the EPRD, there are hardly any outliers in arthroplasty. The EPRD makes a key contribution to the safety of endoprostheses.

Risk of duplicate structures

So there’s a lot to lose. With the development of the IRD, which is also intended to cover implants such as aortic valves and pacemakers, the future of the EPRD has been unclear for more than five years.

Until 2020, everything seemed clear: The Implant Register Act (IRegG) of 2019 explicitly provided for the possibility of appointing an external operating company (e.g., the EPRD) to set up and operate the register. This process can be compared to the TÜV (German Technical Inspection Agency), which is entrusted with the state task of vehicle safety inspections.
“This model would not only have made sense, but also been the simplest,” says Prof. Perka. The idea was supported by then-Health Minister Jens Spahn. However, contrary to the ministerial commitment, a separate department was established within the Federal Ministry of Health without involving the EPRD. There is a rumor in Berlin that the BMG’s unilateral approach was due to individuals in the specialist departments who wanted to make a name for themselves by establishing their own authority.

The separate establishment of a mandatory IRD and a voluntary EPRD would not only entail high costs and a huge loss of expertise. At times, there were very different ideas about the data to be collected and the evaluations to be prepared. While the IRD was only interested in a pure assessment of prosthetic safety, the EPRD continued to insist on concrete data on performance at the implant and hospital levels. Ultimately, there was a risk that hospitals would shy away from the double burden of case reporting and would focus on the mandatory data submission to the IRD.

Cautious Optimism

Speaking to Prof. Perka these days, cautious optimism is spreading. He assesses the current status of the talks as likely again, stating that a sensible solution has become more likely.

“The BMG still absolutely wants to have its own authority and data sovereignty,” Prof. Perka states. However, the latest proposal stipulates that the data will be reported to the IRD in the future and subsequently transferred to the EPRD for much more extensive evaluations. “We are currently coordinating the data set to be recorded so that what we have recorded in the EPRD for 13 years can continue to be recorded.”

Prof. Perka is initially satisfied with the compromise: “The quality of the data was important to us. We can now present 10 years of results. Our goal is to continue analyzing the data so that we can soon present 20 years of results.”

A few challenges still lie ahead: There are different ideas about how the data and the database should be used. In addition, the incoming statutory health insurance data will likely be similar, but not 100% identical. “We will review this with our statutory health insurance partners to ensure comparability with the existing data,” announces Prof. Perka.

More automation, mandatory participation

The optimization of data transfer is also on the agenda during the discussions. Patient data is already recorded in the hospital information systems. The idea is to select the data with one click and transfer it automatically along with the image data. “This would help us to investigate the causes of problems much more specifically,” explains Prof. Perka. “Having such AI-supported systems would also be beneficial for the hospitals for their own more comprehensive evaluations and research work.”

Today, the EPRD voluntarily records around 70% of all knee and hip replacement surgeries performed in the country, with almost 100% follow-up. Mandatory IRD is intended to ensure 100% registration of all procedures. This would represent a further quality boost for the registry – although skepticism remains as to how such a requirement could be enforced with high data quality.

It now remains to be seen how the negotiations between the departments will continue. The joint history of the IRD and EPRD has already gone through a few loops. Let’s therefore follow Prof. Perka, who summarizes the current situation: “If we implement everything we are currently discussing, it could become the best register in the world.”