Development of an instrumented hammer to assess the stability of hip implant during surgery: assessment of the commercial feasibility

Introduction

Total hip replacement is widely used by orthopedic surgeons, with more than one million procedures per year worldwide. Failures still occur because of a bad implant primary stability or the occurrence of fractures, inducing pain and increased costs for the healthcare system. Although implant primary stability is the main determinant of the implant's success, it remains difficult to be assessed in clinical practice.

Project Overview

Impactor is based on results obtained in the ERC CoG project BoneImplant and aims at developing and validating a medical device consisting of a decision support system allowing the surgeon to assess the stability of the acetabular cup and the femoral stem. Such a medical device is needed by clinicians in order to adapt their surgical strategy.

Objectives

The objective of Impactor is to:

1. Achieve a minimum viable product (MVP) that will be validated in vitro and in anatomical subjects.
2. Investigate its commercial potential and design a subsequent commercial exploitation strategy via spin-off creation or licensing of the technology.

We will explore the possibility of licensing the technology to WaveImplant, an already existing spin-off of the same laboratory.

Innovative Approach

The originality of the approach is to use an orthopedic hammer instrumented with piezoelectric sensors, which does not modify the clinical protocol since implants are impacted in bone.

Regulatory Considerations

Regulatory issues will be at the heart of the development, and we will work to clear the regulatory pathway of the future medical device. The team is constituted by members with complementary skills, including engineers, a business developer, and an orthopedic surgeon expert in implantology.

Impact and Vision

Impactor will allow the promotion of innovative solutions and services in orthopedic surgery. The long-term vision is for the technology to become a reference in orthopedic surgery. Strong impacts are associated with Impactor, particularly for:

• Surgeons
• Patients
• Implant manufacturers
• The technology
• The economy