Design of an Affordable, Modular Implant Device for Soft Tissue Tension Assessment and Range of Motion Tracking During Total Hip Arthroplasty.

Background: In hip arthroplasties, surgeons rely on their experience to assess the stability and balance of hip tissues when fitting the implant to their patients. During the operation, surgeons use a modular, temporary set of implants to feel the tension in the surrounding soft tissues and adjust the implant configuration. This process is naturally subjective and therefore depends on the operator. Inexperienced surgeons undertaking hip arthroplasties are twice as likely to experience errors than their experienced colleagues, leading to dislocations, pain and discomfort for the patients. Methods: To address this issue, a new, 3DOF force measurement system was developed and integrated into the modular, trial implants that can quantify forces and movements intraoperatively in 3D. The prototypes were evaluated in three post-mortem human specimens (PMHSs), to provide surgeons with objective data to help determine the optimal implant fit and configuration. The devices comprise a deformable polymer material providing strain-based displacements measured with electromagnetic-based sensors and an inertial measurement unit (IMU) for motion data. Results: Device results show a relative accuracy of approx. 2% and a sensitivity of approx. 1%. PMHS results indicated that soft tissue forces on the hip joint peak in the order of ~100 N and trend with positions of the leg during range of motion (ROM) tests, although force patterns differ between each PMHS. Conclusion: By monitoring forces and force patterns of hip soft tissues, in combination with standardised ROM tests, the force patterns could shed a light on potential anomalies that can be addressed during surgery. Clinical and Translational Impact Statement: The development of an instrumented hip implant device for use during surgery knowledge will eventually allow us to develop a predictive model for soft tissue balancing, that can be used for pre- and intra-operative planning for each patient on a tailored and personalised basis. Ultimately, we hope that with this device, patients will benefit from a faster recovery, from a more-precisely fitted hip, and an improved quality of life.