Encuesta sobre el uso y comportamiento de las prótesis de cadera metal-metal en España / Survey on the use and behaviour of metal-metal hip replacements in Spain

Objetivo. La publicación de alertas en distintos países sobre posibles complicaciones del par metal-metal en las prótesis totales de cadera, indujo a la Agencia Española de Medicamentos y Productos Sanitarios en colaboración con la Sociedad Española de Cirugía de Cadera a diseñar una encuesta de ámbito nacional, con el objetivo de obtener información sobre el uso y comportamiento de estos implantes. Material y método. La encuesta utilizó como instrumento un cuestionario que fue enviado por correo electrónico a 283 centros receptores de prótesis de cadera metal-metal para que fuese cumplimentado por los cirujanos con experiencia en este tipo de implantes. Resultados. El número total de encuestas cumplimentadas fue 257. La tasa global de respuesta de los centros fue del 36,7%. El 97,7% de las encuestas refirieron realizar seguimientos clínicos y radiográficos y el 79,6% analíticos. El 83,6% de las encuestas que habían implantado prótesis de superficie y el 70% de las que habían implantado prótesis con cabeza grande refirieron complicaciones perioperatorias. El fallo más frecuente referido fue el dolor tanto en prótesis de superficie como en prótesis de cabeza grande. Actualmente el 80,8% de las encuestas han referido haber abandonado este tipo de implantes. Conclusiones. A pesar de las numerosas limitaciones del estudio, la encuesta ha permitido obtener de forma rápida un primer contacto con la realidad de la implantación de prótesis de cadera metal-metal en España, y conocer así el perfil de pacientes intervenidos, el periodo de implantación, la experiencia de los cirujanos y el tipo de seguimiento realizado (AU)

Background. Following medical device alerts published in different countries of problems with metal-on-metal total hip replacements, the Spanish Agency of Medicines and Medical Devices (AEMPS) in collaboration with the Spanish Hip Society Surgery designed a national survey to gather information on the use and behaviour of these hip implants. Methods. The survey consisted of a questionnaire sent by e-mail to 283 clinical centre recipients of metal-on-metal hips to be filled in by surgeons with expertise in the field. Results. A total of 257 questionnaires were completed. The response rate of the clinical centres was 36.7%. A total of 97.7% of the responses reported that clinical and radiological follow-ups are carried out, and 79.6% undertook metal ion analyses (chromium and cobalt). A large majority (83.6%) of the responders who had who used surface implants, and 70% of those with large-head implants reported peri-operative complications. The most common complication was pain (25% with surface implants and 30.8% with large-head implants). Currently 80.8% of those responding were considering abandoning implanting of these hip replacements. Conclusions. Despite the many limitations to this study, the survey has allowed us to obtain in a quick first view of the implant scenario of Metal on Metal hip implants in Spain, and to determine the type of patient implanted, the time of implantation, and the experience/expertise of the surgeons, and the type of follow-up carried out (AU)

[Survey on the use and behaviour of metal-metal hip replacements in Spain]. / Encuesta sobre el uso y comportamiento de las prótesis de cadera metal-metal en España.

BACKGROUND: Following medical device alerts published in different countries of problems with metal-on-metal total hip replacements, the Spanish Agency of Medicines and Medical Devices (AEMPS) in collaboration with the Spanish Hip Society Surgery designed a national survey to gather information on the use and behaviour of these hip implants. METHODS: The survey consisted of a questionnaire sent by e-mail to 283 clinical centre recipients of metal-on-metal hips to be filled in by surgeons with expertise in the field. RESULTS: A total of 257 questionnaires were completed. The response rate of the clinical centres was 36.7%. A total of 97.7% of the responses reported that clinical and radiological follow-ups are carried out, and 79.6% undertook metal ion analyses (chromium and cobalt). A large majority (83.6%) of the responders who had who used surface implants, and 70% of those with large-head implants reported peri-operative complications. The most common complication was pain (25% with surface implants and 30.8% with large-head implants). Currently 80.8% of those responding were considering abandoning implanting of these hip replacements. CONCLUSIONS: Despite the many limitations to this study, the survey has allowed us to obtain in a quick first view of the implant scenario of Metal on Metal hip implants in Spain, and to determine the type of patient implanted, the time of implantation, and the experience/expertise of the surgeons, and the type of follow-up carried out.