Exclusive-Interview with Professor Joachim Hassenpflug, EPRD

“Manufacturers are providing strong support for the EPRD”

The new endoprosthesis register aims to catch “outliers” in the field of endoprosthetic care at an early stage, achieving greater transparency and quality in the treatment of arthropathy sufferers. Professor Joachim Hassenpflug explains how the register is structured and the benefits of an interdisciplinary database.

The endoprosthesis register has been launched. What is the current status, who is on board and what degree of coverage are you expecting to achieve by the end of the year?

The register has been set up as a nonprofit limited company and 100% subsidiary of the DGOOC, the German Society for Orthopedics and Orthopedic Surgery. The fact that it is a scientific association ensures that all results are independent. Since it maintains close links with service providers, it also contributes to the implementation of insights as well as improving the quality of results. The German EPRD register is open to all patients. Evaluation is currently available to all AOK and public health insurance patients who have given their consent. This gives us coverage of some 70 percent of all insurees and allows a representative analysis of results quality. There are plans to involve other cost bearers. A feasibility study will be carried out in various hospitals in the autumn of 2011. We plan to start collecting data at the beginning of the second quarter of 2012.

The aim is to develop the endoprosthesis register into a reference database for optimum joint replacement. How have manufacturers responded?

Manufacturers are providing strong support for the register. The sector association BVMed with all its member companies is making a globally unique product database available which encompasses all components of hip and knee endoprostheses fitted in Germany. Using this database, prostheses fitted can be clearly documented when surgery is carried out and then tracked by the register during their lifecycle. A key aspect for manufacturers is that the reasons for revision are recorded in the register.

What do doctors have to say about the initiative?

There has been a very positive response to the endoprosthesis register among doctors Even now, before any data has been collected, many hospitals are contacting the register to state that they will take part. The register gives doctors a transparent, realistic assessment of anticipated quality. This enables them to provide patients with reliable information on prospects and risks during consultation.

The aim of the endoprosthesis database is to reduce the rate of replacement surgery for artificial limbs. Have there been serious problems in this area?

According to studies to date, artificial hip and knee replacement is still one of the most successful surgical methods in terms of giving patients’ their independence. Of around 400,000 artificial hip and knee joints fitted every year in Germany, however, there are about 35,000 which have to be replaced after varying lengths of time. This rate will be reliably documented in the EPRD, with a focus on the parameters for success or failure.

What do you regard as the potential success rate and therefore the possible savings in terms of care costs?

In Sweden the introduction of a register led to the revision rate being reduced by half. If you apply the experience of Sweden to Germany by way of a projection, a conservative estimate would be an annual saving in the double-digit millions since the rate of early revisions and long-term replacements would be reduced accordingly.

The register is based on information provided by hospitals and manufacturers. Botched cases are hardly likely to be reported – how reliable are the results?

The lifetime of prostheses is calculated by analyzing the routine data passed on by hospitals when they charge the insurance companies. These data are highly reliable for various reasons. Firstly, every hospital will want to charge for performing surgery. Secondly, the details of prosthesis fitting and revision surgery provide a “hard” data set which is practically impossible to manipulate. What is more, a certain percentage of the details regularly undergo a systematic verification procedure. The product database allows clear identification of the prosthetic parts fitted. This means that the reliability of the data cannot be circumvented by either hospitals or manufacturers.

Material defects or sloppy manufacturing are quick to uncover since manufacturers are subject to stringent regulatory quality criteria. Does mean that defective surgery or professional malpractice on the part of doctors is usually to blame when implants are poorly fitted?

The current data available is not sufficient to be able to answer this question with certainty. Failed artificial joint replacement can be caused by a combination of various elements. The assumption is that most cases of early revision surgery within the first few years of fitting are more likely to be linked to the surgery itself than the implants used. With its extensive data pool, the German endoprosthesis register will be able to provide information on whether revision surgery was a result of the implants used, the surgical procedure or patient-specific factors.

Interview conducted by Andreas Beuthner  

German Summary

Das neue Endoprothesenregister will frühzeitig „Ausreißer“ in der endoprothetischen Versorgung erfassen und damit mehr Transparenz und Qualität in die Behandlung gelenkerkrankter Patienten hineintragen. Prof. Joachim Hassenpflug, Geschäftsführer Deutsche Endoprothesenregister gGmbH (EPRD) erklärt, wie das Register aufgebaut ist und welche Chancen eine interdisziplinäre Datenbank hat. Hassenpflugs Befund ist eindeutig: „Die Hersteller unterstützen das EPRD nachdrücklich.“ Denn: „Es wird vermutet, dass ein Großteil der frühen Wechseloperationen innerhalb der ersten Jahre nach dem Protheseneinbau weniger mit den verwendeten Implantaten, sondern eher mit den Operationsverfahren in Verbindung zu bringen ist.“ Der deutschsprachige Beitrag ist nachzulesen auf www.meditec-international.com/medi0311hass