A prospective single arm post market clinical follow‐up study to evaluate the safety and performance of radius system intended for radius fracture fixation.

Fractures of the radius bone in the forearm are a common orthopedic injury, often resulting from accidents, falls, or sports-related activities. These fractures can lead to functional impairment, pain, and decreased quality of life for subjects. This type of fracture is particularly prevalent among individuals of all ages, from children to older adults, due to the vulnerability of the forearm bones during activities that involve impact or high force. Radius fractures can vary in severity, ranging from a small crack in the bone to a complete break that causes the bone to shift out of place. Understanding the causes, symptoms, and treatment options for radius fractures is crucial in effectively managing and recovering from this injury. Medical intervention, including accurate diagnosis, immobilization, and rehabilitation, plays a significant role in restoring functionality and reducing long-term complications. To facilitate the healing process and restore proper function, medical professionals often employ surgical interventions, with radius plates being a widely used treatment option. Radius plates serve as an internal fixation device, providing stability and support to the fractured bone during the healing process. These plates are typically composed of biocompatible materials, such as titanium or stainless steel, and are designed to withstand the physiological loads placed on the radius. This protocol outlines a comprehensive study aimed at investigating the safety and effectiveness of radius plates for the management of radius fractures. The study will encompass a range of factors, including subject outcomes, biomechanical analysis, and the identification of potential complications or adverse effects associated with radius plate fixation. The primary objective of this study will be to assess the safety of radius plates by analyzing the occurrence of postoperative complications, such as infection, implant failure, and nerve or blood vessel damage. Long- term follow-up will be conducted to monitor the progress of fracture healing, range of motion, grip strength, and subject-reported outcomes, including pain levels and satisfaction with treatment. Additionally, the effectiveness of radius plates will be evaluated by examining the rate of fracture union and restoration of bone alignment. Radiographic analysis will be performed to assess the degree of bone healing, alignment, and any signs of implant failure or loosening. Functional outcomes, such as wrist motion, forearm rotation, and grip strength, will be measured and compared to preoperative values to determine the efficacy of radius plate fixation in restoring normal function. Furthermore, biomechanical analysis will be conducted to assess the grip strength by Jamar dynamometer. In conclusion, this protocol outlines a comprehensive study designed to evaluate the safety and effectiveness of radius plates for the treatment of radius fractures.