OBJECTIVES: Real-world evidence (RWE) on effectiveness and benefits of medical technologies is gaining importance in decision-making on reimbursement. The objective of this study was to evaluate the use of ADAPT for Gamma3, an augmented reality technology to enhance nail alignment, to treat proximal femur hip fractures in a real-world setting by assessing its effectiveness, benefits of the device, and surgeons’ satisfaction.

METHODS: From November 2018 to March 2019, a survey was conducted among surgeons in Belgium, Denmark, Finland, France, Germany, Italy, Spain, UK, and USA. Data was collected on effectiveness regarding procedure duration, support for lag screw planning and insertion, and support for distal targeting and locking (i.e. number of X-ray shots). Additionally, case details as well as data on main benefits and surgeons’ satisfaction were obtained.

RESULTS: In total, 29 surgeons participated and reported feedback on 54 surgical cases. Median procedure duration was 40 minutes (range 15 mins - 2 hours). Median TAD (Tip-Apex Distance) was 12mm (n=46 cases) and all reported values were below the generally acknowledged threshold of 25mm. Median TSD (Tip-Surface Distance) was 5mm (n=40 cases) with a narrow interquartile range of 1mm. Median number of X-ray shots for distal locking was five (n=26 cases) with an interquartile range of 5.25 (range 2 - 13 shots). Main benefits most frequently reported were: accuracy of lag screw placement with intraoperative TAD measurement and adjustability, shorter procedure durations, reduced X-ray exposure, support for distal targeting and locking, system ease of use and K-wire placement in the femoral head. Overall satisfaction was high, with surgeons responding on the positive side of the satisfaction scale in 89% of cases.

CONCLUSIONS: The effectiveness, benefits, and surgeon satisfaction of using ADAPT for Gamma3 to treat hip fractures were confirmed in a real-world setting. This RWE can aid reimbursement decision-making of ADAPT.