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Dispelling Myths about Endoprosthetics
Three crucial success factors
“The success of a joint replacement not only depends on the product. However, it is equally dependent on the surgeon, the patient and, of course, the implant” explained Michel. The experts went on to also stress the necessity of adequate advanced training courses for endoprosthetic surgeons to upgrade their skills and called for an obligatory participation of hospitals in the medical association’s existing endoprosthesis register. The experts agreed that a legally binding participation would contribute to quickly and effectively reach the required number of participants.
Strict approval process
Michel pointed out that the approval process for endoprostheses in Germany under the German Medical Devices Act (MPG) applies the strictest approval criteria of class III medical devices. “This includes, among others, a risk analysis and a clinical investigation. Compliance with the strict requirements is reviewed by an accredited, nationally recognized auditing and certification body operating under private law such as TÜV or DEKRA. Furthermore, the clinical study must be approved by an ethics committee and by the German Federal Institute for Drugs and Medical Devices (BfArM)“, explained Michel.
Growth market endoprosthetics
Hip replacement surgery has become a routine procedure. Every year, approximately 400,000 patients in Germany receive a joint replacement. In 2010 approximately 210,000 hip replacements and 165,000 knee replacements were implanted. Then there are shoulder joint, cubital joint, finger joint, ankle joint and basic hallux joint endoprostheses. The increasing life expectancy of the population in the industrial countries leads to increased cases of joint wear and thus, a rising demand for hip and knee replacement operations. “Joint replacements mark the end of the treatment chain“, says Prof. Dr. Thorsten Gehrke. “More than 95 percent of the implants have a life expectancy of more than 10 years and the complication rate is very low with under 2 percent“, explained Gehrke. The causes for complications are diverse and mostly include aseptic loosening (57.8 percent) and joint dislocation (11.8 perecent). With a mere 1.4 percent, implant fractures are a rare indication for revision surgery.
