L’clinical trial called “ACTISURF-OI-16” aimed to evaluate the integration of a new total hip prosthesis Actifsurf-Cerafid from Ceraver and its ability to limit the risk of bacterial infection during the surgical operation due to its surface coating. The comparison was made with the Cerafit reference prosthesis already on the market.
Seven surgical departments, including the orthopedic surgery department of the Ambroise-Paré AP-HP hospital located in Boulogne-Billancourt, are participating in this research and approximately 340 patients were included between 2017 and April 2023.
Adverse effects concerning an increased risk of loosening of the prosthesis in implanted patients having been reported (as well as various breaches of regulations), the National Agency for the Safety of Medicines and Health Products (ANSM) has decided to take a decision health police against the promoter Ceraver to partially suspend this research and strengthen patient monitoring [1].
Inform included patients
Participants in this research will receive a letter from their orthopedic surgeon informing them of the type of prosthesis implanted and, depending on the model, the action to take.
In particular, in the case of an Actisurf-Cerafit hip prosthesis, a clinical and radiological control appointment will be scheduled with the surgeon within 3 months..
In the event of pain and/or a noise coming from the hip, the surgeon must be contacted immediately so that the condition of the prosthesis can be checked.
Related News :