Impact-BAsed Surgical InstruMentation using Artifical Intelligence – IBAM

Over the last 40 years, surgical procedures involving modifications of bone tissue such as the implants surgery or osteotomies have experienced rapid development, particularly because of the increase in life expectancy. However, the instrumentation used during these surgical procedures has remained relatively basic and these procedures are still largely based on the surgeon's proprioception. Moreover, there remains a risk of failure that could have dramatic consequences for the patient.
In particular, the primary stability of uncemented implants remains difficult to assess intraoperatively, although it is a strong determinant of the surgical success. Moreover, osteotomies, which aim to cut bone tissue, remain a delicate procedure because too strong impacts can lead to uncontrolled bone fractures. These two types of surgical interventions have in common the fact that they are carried out using a surgical hammer used to impact the instrument holding the implant or osteotome. In both cases, controlling the number and amplitude of impacts determines surgical success.
The general objective of IBAM is to introduce smart tools into the instrumentation used for bone surgery to provide quantitative information on the biomechanical properties of bone tissues. In particular, we will extend the use of an instrumented hammer equipped with piezoelectric sensors initially developed for hip surgery to the placement of other implants (knee, shoulder, ankle) and to the realization of osteotomies in maxillofacial and orthopedic surgery. This smart hammer will provide a decision support system helping surgeons to adapt their surgical protocol in a patient-specific manner without modifying the surgical protocol.
The innovative nature of IBAM lies in the development of medical devices allowing to provide quantification in a field where the surgeon's proprioception is still widely used (e.g. touch and hearing). We will develop prototypes respecting all regulatory issues and adapted to the requirements for a future use in a clinical environment. The medical devices will have to be validated via clinical trials following the end of IBAM. To do this, we will work on the validation protocol and on the device (hammer size, data processing, sensors, etc.). We will implement artificial intelligence techniques such as classification methods like Support Vector Machine in order to improve the performance of the device. The innovation is based on the possibility of obtaining a quantitative evaluation of the implant stability or the biomechanical properties of the bone located around the osteotome.
The translational nature of the project is attested to by the fact that its objective is to integrate for the first time the instrumented hammer technique (used in the field of non-destructive testing) in the medical field. The approach has the following advantages. First, it leads to integration of the device into the operating room. Second, the device is not in direct contact with the patient, which minimizes the risk of infection. Third, the method does not require any modification to the surgical procedure, making it easy for surgeons to use and thereby maximizing the chances of mass adoption by surgeons.
IBAM will rely on the feasibility studies carried out by the IMRB in the context of total hip prosthesis and on technological developments in the field of biomedical engineering from ImpacTell. The IMRB will provide ImpacTell with knowledge of clinical issues as well as the possibility of carrying out experimental validations. ImpacTell will bring the smart hammer technology to the IMRB as well as skills in biomechanics and in the field of artificial intelligence.