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period, and that nevertheless hardened quickly. In ad-dition, unlike dental materials, bone cement had to be sterilized and impregnated with an X-ray contrast agent. Heraeus Kulzer’s* expertise in manufacturing dental materials and understanding of polymer methacrylates good again!
led to a second, relatively fast-expanding copolymer that achieved the viscosity required. In 1943, Kulzer* patented the first cold-hardening bone cement. As with plexiglass, polymethylmethacrylate (PMMA) is a major component Palacos® Bone Cement from Heraeus has set of the bone cement. In contrast to plexiglass production, however, the PMMA polymerizes of its own accord and standards in hip prosthesis for almost 50 years In 1959, the highly viscous bone cement from Kulzer* was finally introduced onto the market under the name Palacos®. To this day it is successfully used in hip and knee endoprosthetics. Numerous studies and indepen-dent sources have confirmed its effectiveness. From long Feeling good is related to mobility – as long as you can go
term studies, for example, it can be demonstrated that anywhere without problems, you are basically well. But as
there is a comparatively low risk of revision for prosthetics we age, this is often no longer possible, especially if worn
cemented with Palacos®. The risk of revision indicates the out hip joints make every step a torture. One solution is
probability that an endoprosthesis will have to be removed an artificial hip joint, which provides renewed stability and
or reset. Such long term studies are facilitated among mobility. Palacos® Bone Cement from Heraeus plays an
other things by the Swedish hip registry, a database in important role in this.
which virtually all hip operations in Sweden and parts of Scandinavia are documented.
The implantation of a hip endoprosthesis is today consid- ered a routine operation, and there are various methods Palacos® has been on the market for almost 50 years: of implanting the artificial joint into the bone. The first “This bone cement is distinguished by reliable, well docu- hip endoprostheses were cemented in the 1950’s, and mented mechanical properties,” says Dr. André Kobelt, since then the operation and the cementing technology General Manager of Heraeus Kulzer and Director of the have been developed further. With Palacos® Bone Cement, Heraeus Medical division, founded in 2004. “There are Heraeus has been setting the standard in Europe and the relatively few medical products and medicines which have USA for over 47 years when it comes to anchoring hip been observed and studied over such a long period of prostheses securely to the bone. Furthermore, it has also time.” Thanks to this technique, it has also been pos- proven effective as a base for antibiotics, thus reducing sible – in situations where modern, optimized cementing technology is used – to achieve long service lives of up to 25 years from the prostheses, according to the specialist.
Palacos® can be described as a classic. For almost 50 years, this product has continued to set new standards for bone Avoiding infections
cements like no other. It’s a story of innovation that goes Infection and the often associated prothesis loosening can back to the early 1940’s. Back then, researcher Dr. Diener necessitate the removal and replacement of prostheses. at Kulzer & Co.*, a subsidiary of the Heraeus group, had In order to prevent such bacterial infections, antibacterial the idea of developing a bone cement from a special plastic agents have been added to bone cement since the end used in dentistry for use in other branches of medicine. of the 1960’s. As early as 1972, bone cement contain- The dental plastics were initially too fluid to be success- ing gentamicin was marketed under the name Refobacin® fully processed. The challenge: a highly viscous cement Palacos®. The specialists reacted to the increasing variety had to be developed that would cease to be sticky after of bacteria and resistance to antibacterial agents with only a short time, that allowed a reasonable processing additional products for infected revisions. Thus in addition to Copal® (with the broadband antibiotics gentamicin and * Important editorial note regarding the historical relationship between the clindamycin, which is effective against streptococcus), companies mentioned and the development of Palacos bone cement: the company was still called Kulzer & Co. at that time, and was a subsidiary of the Heraeus group. Heraeus Kulzer GmbH was only created in 1990, by the merger of Heraeus Edelmetall GmbH and Kulzer GmbH.
technology report 2008
technology report 2008
bone cement containing two antibiotics was recently ap-proved, which is particularly useful in cases of gentamicin Endoprosthesis: cemented
resistance. The cements containing antibiotics are charac- and cement-free
terized by a high release rate of the agents, and prevent a bacterial infection during and after surgery. As life expectancy increases, so does the inci-
dence of wear-related joint ailments. For that
Green coloring helps the surgeon
reason, the number of artificial hip and knee joints
The Palacos® family has continued to grow in recent years. implanted has increased significantly in recent
In response to the demands of the medical profession, decades. Hundreds of thousands of hip opera-
Heraeus now offers bone cements for various requirements. tions are now performed worldwide each year: in
A cement for filling out and stabilizing vertebral bodies Germany alone, around 147,000 hip endopros-
and marketed under the name Osteopal® is now avail- thesis primary implantations were performed in
able. Due to the addition of zirconium dioxide (ZrO2), all 2006, and the number of knee endoprosthesis
of these bone cements display a good degree of imperme- primary implantations are increasing significantly
ability to X-rays, and thus allow physicians to more easily from year to year. Since the first hip endoprosthe-
perform postoperative follow-up and progress checks. ses were cemented in the 1950’s, surgical and
cementing technologies have come a long way.
What is the significance of the characteristic green color- With or without cement: both methods are used
ing of the Palacos® products? The coloring, produced by equally alongside a few special forms. In each in-
the addition of chlorophyll, is not merely a trademark. It dividual case, the physician decides which method
is helpful for the surgeon, and also during processing, as is preferable.
it is immediately clear where the bone cement is. “Cor- rect mixing and rapid processing at the right time require well-trained personnel,” emphasizes bone cement special-ist Kobelt. The temperature of the prosthetic material and cement components, and the humidity level in the operating room, also play a role. The quality of the bone cement is therefore not the only factor in the durability of Comparison of Endoprosthetics*
a cemented prosthesis: correct mixing of the components and modern cementing technology are also vital for lasting Cement free method
Cemented method
Requires lengthy recuperation after the operation A look to the future
Under the terms of the German Medicines Act of 1972, Bone cements containing antibiotics prevent infection Heraeus was obliged to transfer the approval and market- Bone cement stabilizes bone material close to the prosthesis ing of Palacos® to other companies. The manufacturing Bone cement has elastic and cushioning effects rights to the product remained with Heraeus, however. Since 1998, bone cements have no longer been consid- *this overview makes no claim of completeness ered drugs under the Medicines Act. In 2004, the sub- The green coloring of the bone cement helps during operations.
sidiary Heraeus Medical was founded to facilitate direct marketing of the bone cements in Europe. Since then, the new company has built up its own direct sales in most EU countries. In the first quarter of 2007, Palacos® regis- Heraeus is also planning innovative products for other in complications. The risk of infection can therefore not tered a market share of 50 percent in Europe, and about branches of orthopedic surgery. Physicians frequently be reduced here by antibiotics contained in bone cements: 20 percent in the USA. Heraeus Medical entered the choose to perform endoprosthetics without cement, espe- “For titanium prosthetics, we have developed a special Asian market in 2007. “We are working with distributors cially for younger patients, whose stable bone structure coating containing antibiotic agents: a gentamicin palmi- in Malaysia, Thailand, Indonesia, Singapore, the Philip- enables the prosthesis to grow in well. The titanium pros- tate is used, which forms a waxy coating and releases the pines and New Zealand, and we initiated direct sales in theses used in such cases have to be implanted without agent very well,” Kobelt describes the promising innova- Want to know more?
Australia in July,” says Kobelt. “A whole series of product bone cement, as the cement would rub off the oxide layer tion. With this development, Heraeus is opening up new innovations are currently in the introductory phase.” of the titanium like sandpaper, which in turn would result opportunities in the cement-free endoprosthesis market. Sales Manager EuropeHeraeus Medical Philipp-Reis-Str. 8/13, 61273 Wehrheim / Ts.
Phone: + 49 (0) 6181.35-29 01E-mail: christian.zimmermann@heraeus.com technology report 2008
technology report 2008

Source: http://konzern.heraeus.de/media/webmedia_local/media/innovation/innovationheraeus/httensiesgewusst/Palacos_technology_report2008_E.pdf